Frequencies for enfrep20170920 dataset : by Jean Roth , jroth@nber.org , 21 Sep 2017 Frequencies for producttype variable in enfrep20170920 dataset : Product | Type | Freq. Percent Cum. ------------+----------------------------------- Biologics | 2 2.67 2.67 Devices | 22 29.33 32.00 Drugs | 29 38.67 70.67 Food | 22 29.33 100.00 ------------+----------------------------------- Total | 75 100.00 Frequencies for eventid variable in enfrep20170920 dataset : Event ID | Freq. Percent Cum. ------------+----------------------------------- 76905 | 2 2.67 2.67 76909 | 1 1.33 4.00 77444 | 1 1.33 5.33 77554 | 1 1.33 6.67 77614 | 1 1.33 8.00 77650 | 1 1.33 9.33 77664 | 2 2.67 12.00 77768 | 1 1.33 13.33 77812 | 1 1.33 14.67 77843 | 1 1.33 16.00 77882 | 1 1.33 17.33 77888 | 1 1.33 18.67 77896 | 1 1.33 20.00 77936 | 1 1.33 21.33 77948 | 1 1.33 22.67 77949 | 1 1.33 24.00 77950 | 2 2.67 26.67 77959 | 16 21.33 48.00 77963 | 1 1.33 49.33 77968 | 1 1.33 50.67 77989 | 1 1.33 52.00 77990 | 2 2.67 54.67 77998 | 1 1.33 56.00 77999 | 1 1.33 57.33 78007 | 17 22.67 80.00 78039 | 1 1.33 81.33 78049 | 2 2.67 84.00 78055 | 7 9.33 93.33 78067 | 1 1.33 94.67 78072 | 1 1.33 96.00 78075 | 1 1.33 97.33 78080 | 1 1.33 98.67 78085 | 1 1.33 100.00 ------------+----------------------------------- Total | 75 100.00 Frequencies for status variable in enfrep20170920 dataset : Status | Freq. Percent Cum. ------------+----------------------------------- Ongoing | 72 96.00 96.00 Terminated | 3 4.00 100.00 ------------+----------------------------------- Total | 75 100.00 Frequencies for recallingfirm variable in enfrep20170920 dataset : Recalling Firm | Freq. Percent Cum. ----------------------------------------+----------------------------------- Aidarex Pharmaceuticals LLC | 1 1.33 1.33 Andropharm, LLC | 2 2.67 4.00 Ascend Laboratories LLC | 1 1.33 5.33 BESTHERBS COFFEE LLC | 1 1.33 6.67 Bateman Community Living | 1 1.33 8.00 Baxter Healthcare Corp | 1 1.33 9.33 Beckman Coulter Inc. | 1 1.33 10.67 Becton Dickinson & Company | 1 1.33 12.00 Bella Pharmaceuticals, Inc. | 16 21.33 33.33 Boston Scientific Corporation | 1 1.33 34.67 Centurion Labs, LLC | 2 2.67 37.33 Chiavna Saffron LLC | 1 1.33 38.67 Fujifilm Medical Systems U.S.A., Inc. | 2 2.67 41.33 Implant Direct Sybron Manufacturing, .. | 1 1.33 42.67 Leica Biosystems Richmond Inc. | 7 9.33 52.00 Leonhard Lang Medizintechnik GmbH | 1 1.33 53.33 LifeShare Blood Centers | 1 1.33 54.67 MEDLINE INDUSTRIES INC | 1 1.33 56.00 Mako Surgical Corporation | 2 2.67 58.67 Mid Valley Pharmaceutical | 2 2.67 61.33 Monster Energy Company | 1 1.33 62.67 OneBlood, Inc. | 1 1.33 64.00 Orthofix, Inc | 1 1.33 65.33 Rolnicza Spoldzielnia Produkcyjna Zlo.. | 1 1.33 66.67 The Harvard Drug Group | 17 22.67 89.33 Tomanetti Food Products Inc | 1 1.33 90.67 Toshiba American Medical Systems | 1 1.33 92.00 VistaPharm, Inc. | 1 1.33 93.33 Wegmans Food Markets, Inc. | 1 1.33 94.67 X-Laser Llc | 1 1.33 96.00 Zimmer Biomet, Inc. | 1 1.33 97.33 Zydus Pharmaceuticals USA Inc | 1 1.33 98.67 bioMerieux, Inc. | 1 1.33 100.00 ----------------------------------------+----------------------------------- Total | 75 100.00 Frequencies for address1 variable in enfrep20170920 dataset : Address1 | Freq. Percent Cum. -------------------------------+----------------------------------- 1 Becton Dr | 1 1.33 1.33 1 Monster Way | 1 1.33 2.67 10 Highpoint Dr | 2 2.67 5.33 100 Boston Scientific Way | 1 1.33 6.67 100 Rodolphe St | 1 1.33 8.00 1140 Holland Dr | 2 2.67 10.67 14235 Boren St | 1 1.33 12.00 1500 Brooks Ave | 1 1.33 13.33 17177 N Laurel Park Dr Ste 233 | 17 22.67 36.00 180 Summit Ave Ste 200 | 1 1.33 37.33 1800 W Center St | 1 1.33 38.67 1900 Highway 201 N | 1 1.33 40.00 2420 E Arkansas Ln Ste 216 | 1 1.33 41.33 2441 Michelle Dr | 1 1.33 42.67 250 S Kraemer Blvd | 1 1.33 44.00 2555 Davie Rd Ste 110 | 2 2.67 46.67 3 Lakes Dr | 1 1.33 48.00 3050 E Hillcrest Dr | 1 1.33 49.33 3100 Bowling Dr | 2 2.67 52.00 3101 W Devon Ave | 16 21.33 73.33 3451 Plano Pkwy | 1 1.33 74.67 5205 Route 12 | 7 9.33 84.00 595 N Smith Ave Ste B | 1 1.33 85.33 625 Allegheny Ave | 1 1.33 86.67 7265 Ulmerton Rd | 1 1.33 88.00 73 Route 31 N | 1 1.33 89.33 849 F St | 1 1.33 90.67 8669 Commodity Cir | 1 1.33 92.00 8910 Linwood Ave | 1 1.33 93.33 910 E Hidalgo Ave | 2 2.67 96.00 9125 Whiskey Bottom Rd Ste A | 1 1.33 97.33 Archenweg 56 | 1 1.33 98.67 Ulica Wojewodzka 12 | 1 1.33 100.00 -------------------------------+----------------------------------- Total | 75 100.00 Frequencies for address2 variable in enfrep20170920 dataset : Address2 | Freq. Percent Cum. ------------+----------------------------------- | 68 90.67 90.67 Apt 201 | 1 1.33 92.00 Ste 12 | 2 2.67 94.67 Suite 1 | 2 2.67 97.33 Suite 3 | 2 2.67 100.00 ------------+----------------------------------- Total | 75 100.00 Frequencies for city variable in enfrep20170920 dataset : City | Freq. Percent Cum. -----------------+----------------------------------- Arlington | 1 1.33 1.33 Birmingham | 2 2.67 4.00 Boca Raton | 2 2.67 6.67 Brea | 1 1.33 8.00 Chicago | 16 21.33 29.33 Corona | 2 2.67 32.00 Davie | 2 2.67 34.67 Durham | 1 1.33 36.00 Franklin Lakes | 1 1.33 37.33 Huntersville | 1 1.33 38.67 Innsbruck | 1 1.33 40.00 Largo | 1 1.33 41.33 Laurel | 1 1.33 42.67 Lewisville | 1 1.33 44.00 Livonia | 17 22.67 66.67 Marlborough | 1 1.33 68.00 Montvale | 1 1.33 69.33 Mountain Home | 1 1.33 70.67 Northfield | 1 1.33 72.00 Oakmont | 1 1.33 73.33 Orlando | 1 1.33 74.67 Pennington | 1 1.33 76.00 Raymondville | 2 2.67 78.67 Richmond | 7 9.33 88.00 Rochester | 1 1.33 89.33 Shreveport | 1 1.33 90.67 Tustin | 1 1.33 92.00 Warsaw | 1 1.33 93.33 Wayne | 2 2.67 96.00 West Sacramento | 1 1.33 97.33 Westlake Village | 1 1.33 98.67 Zlotoklos | 1 1.33 100.00 -----------------+----------------------------------- Total | 75 100.00 Frequencies for stateprovince variable in enfrep20170920 dataset : State/Provi | nce | Freq. Percent Cum. ------------+----------------------------------- | 2 2.67 2.67 AL | 2 2.67 5.33 AR | 1 1.33 6.67 CA | 6 8.00 14.67 FL | 6 8.00 22.67 IL | 24 32.00 54.67 IN | 1 1.33 56.00 LA | 1 1.33 57.33 MA | 1 1.33 58.67 MD | 1 1.33 60.00 MI | 17 22.67 82.67 NC | 2 2.67 85.33 NJ | 5 6.67 92.00 NY | 1 1.33 93.33 PA | 1 1.33 94.67 TX | 4 5.33 100.00 ------------+----------------------------------- Total | 75 100.00 Frequencies for postalcode variable in enfrep20170920 dataset : Postal Code | Freq. Percent Cum. ------------+----------------------------------- | 2 2.67 2.67 01752-1234 | 1 1.33 4.00 07417-1815 | 1 1.33 5.33 07470-7431 | 2 2.67 8.00 07645-1722 | 1 1.33 9.33 08534-3601 | 1 1.33 10.67 14624-3512 | 1 1.33 12.00 15139-2003 | 1 1.33 13.33 20723-1333 | 1 1.33 14.67 27712-9402 | 1 1.33 16.00 28078-6516 | 1 1.33 17.33 32819-9003 | 1 1.33 18.67 33317-7424 | 2 2.67 21.33 33487-2764 | 2 2.67 24.00 33771-4809 | 1 1.33 25.33 35242-6588 | 2 2.67 28.00 46580-2304 | 1 1.33 29.33 48152-3951 | 17 22.67 52.00 60071 | 7 9.33 61.33 60093-2753 | 1 1.33 62.67 60659-1407 | 16 21.33 84.00 71106-6508 | 1 1.33 85.33 72653-2433 | 1 1.33 86.67 75056-9453 | 1 1.33 88.00 76014-1753 | 1 1.33 89.33 78580-4095 | 2 2.67 92.00 91362-3171 | 1 1.33 93.33 92780-7047 | 1 1.33 94.67 92821-6232 | 1 1.33 96.00 92879-7101 | 1 1.33 97.33 92880-6920 | 1 1.33 98.67 95605-2313 | 1 1.33 100.00 ------------+----------------------------------- Total | 75 100.00 Frequencies for country variable in enfrep20170920 dataset : Country | Freq. Percent Cum. --------------+----------------------------------- Austria | 1 1.33 1.33 Poland | 1 1.33 2.67 United States | 73 97.33 100.00 --------------+----------------------------------- Total | 75 100.00 Frequencies for voluntarymandated variable in enfrep20170920 dataset : Voluntary/Mandated | Freq. Percent Cum. --------------------------+----------------------------------- FDA Mandated | 2 2.67 2.67 Voluntary: Firm Initiated | 73 97.33 100.00 --------------------------+----------------------------------- Total | 75 100.00 Frequencies for initialfirmnotificationofconsign variable in enfrep20170920 dat Initial Firm Notification of Consignee | or Public | Freq. Percent Cum. ----------------------------------------+----------------------------------- E-Mail | 10 13.33 13.33 FAX | 1 1.33 14.67 Letter | 17 22.67 37.33 Press Release | 22 29.33 66.67 Telephone | 17 22.67 89.33 Two or more of the following: Email, .. | 6 8.00 97.33 Visit | 2 2.67 100.00 ----------------------------------------+----------------------------------- Total | 75 100.00 Frequencies for distributionpattern variable in enfrep20170920 dataset : Distribution Pattern | Freq. Percent Cum. ----------------------------------------+----------------------------------- Distributed to the state of CA and NV. | 1 1.33 1.33 Distribution US nationwide. | 1 1.33 2.67 Distribution was made to distributors.. | 1 1.33 4.00 Domestic: Nationwide to USA Foreig.. | 17 22.67 26.67 Florida | 3 4.00 30.67 Louisiana | 1 1.33 32.00 MA, MD, NJ, NY, NY, PA, VA | 1 1.33 33.33 NY to one distributor | 1 1.33 34.67 Nationwide | 3 4.00 38.67 Nationwide Distribution to AR, AZ, CA.. | 7 9.33 48.00 Nationwide in the USA. | 1 1.33 49.33 Nationwide within USA | 16 21.33 70.67 Nationwide within United States | 1 1.33 72.00 Nationwide. | 2 2.67 74.67 One customer in California | 1 1.33 76.00 PA | 1 1.33 77.33 Recalling firm only distributed to 2 .. | 1 1.33 78.67 TX | 2 2.67 81.33 To distributors in KS, MS, HI, NC, AL.. | 1 1.33 82.67 US Distribution | 1 1.33 84.00 US Distribution to one customer in Mi.. | 1 1.33 85.33 US Distribution to: TX, PA, VA, CA, N.. | 1 1.33 86.67 US Nationwide Distribution | 2 2.67 89.33 USA (nationwide) Distribution | 1 1.33 90.67 Worldwide - US Nationwide Distributio.. | 2 2.67 93.33 Worldwide Distribution - US (nationwi.. | 1 1.33 94.67 Worldwide Distribution - USA (nationw.. | 1 1.33 96.00 Worldwide Distribution: US (nationwid.. | 1 1.33 97.33 Worldwide distribution. US distributi.. | 1 1.33 98.67 nationwide, Canada | 1 1.33 100.00 ----------------------------------------+----------------------------------- Total | 75 100.00 Frequencies for recallnumber variable in enfrep20170920 dataset : Recall | Number | Freq. Percent Cum. ------------+----------------------------------- B-0862-2017 | 1 1.33 1.33 B-0865-2017 | 1 1.33 2.67 D-1134-2017 | 1 1.33 4.00 D-1135-2017 | 1 1.33 5.33 D-1136-2017 | 1 1.33 6.67 D-1137-2017 | 1 1.33 8.00 D-1138-2017 | 1 1.33 9.33 D-1139-2017 | 1 1.33 10.67 D-1140-2017 | 1 1.33 12.00 D-1141-2017 | 1 1.33 13.33 D-1142-2017 | 1 1.33 14.67 D-1143-2017 | 1 1.33 16.00 D-1144-2017 | 1 1.33 17.33 D-1145-2017 | 1 1.33 18.67 D-1146-2017 | 1 1.33 20.00 D-1147-2017 | 1 1.33 21.33 D-1148-2017 | 1 1.33 22.67 D-1149-2017 | 1 1.33 24.00 D-1150-2017 | 1 1.33 25.33 D-1151-2017 | 1 1.33 26.67 D-1152-2017 | 1 1.33 28.00 D-1153-2017 | 1 1.33 29.33 D-1154-2017 | 1 1.33 30.67 D-1155-2017 | 1 1.33 32.00 D-1156-2017 | 1 1.33 33.33 D-1157-2017 | 1 1.33 34.67 D-1158-2017 | 1 1.33 36.00 D-1159-2017 | 1 1.33 37.33 D-1160-2017 | 1 1.33 38.67 D-1161-2017 | 1 1.33 40.00 D-1162-2017 | 1 1.33 41.33 F-3515-2017 | 1 1.33 42.67 F-3516-2017 | 1 1.33 44.00 F-3517-2017 | 1 1.33 45.33 F-3518-2017 | 1 1.33 46.67 F-3519-2017 | 1 1.33 48.00 F-3520-2017 | 1 1.33 49.33 F-3521-2017 | 1 1.33 50.67 F-3522-2017 | 1 1.33 52.00 F-3523-2017 | 1 1.33 53.33 F-3524-2017 | 1 1.33 54.67 F-3525-2017 | 1 1.33 56.00 F-3526-2017 | 1 1.33 57.33 F-3527-2017 | 1 1.33 58.67 F-3528-2017 | 1 1.33 60.00 F-3529-2017 | 1 1.33 61.33 F-3530-2017 | 1 1.33 62.67 F-3531-2017 | 1 1.33 64.00 F-3540-2017 | 1 1.33 65.33 F-3541-2017 | 1 1.33 66.67 F-3542-2017 | 1 1.33 68.00 F-3543-2017 | 1 1.33 69.33 F-3545-2017 | 1 1.33 70.67 Z-2870-2017 | 1 1.33 72.00 Z-3109-2017 | 1 1.33 73.33 Z-3111-2017 | 1 1.33 74.67 Z-3115-2017 | 1 1.33 76.00 Z-3116-2017 | 1 1.33 77.33 Z-3117-2017 | 1 1.33 78.67 Z-3118-2017 | 1 1.33 80.00 Z-3119-2017 | 1 1.33 81.33 Z-3120-2017 | 1 1.33 82.67 Z-3121-2017 | 1 1.33 84.00 Z-3122-2017 | 1 1.33 85.33 Z-3123-2017 | 1 1.33 86.67 Z-3124-2017 | 1 1.33 88.00 Z-3125-2017 | 1 1.33 89.33 Z-3126-2017 | 1 1.33 90.67 Z-3127-2017 | 1 1.33 92.00 Z-3128-2017 | 1 1.33 93.33 Z-3129-2017 | 1 1.33 94.67 Z-3130-2017 | 1 1.33 96.00 Z-3131-2017 | 1 1.33 97.33 Z-3132-2017 | 1 1.33 98.67 Z-3133-2017 | 1 1.33 100.00 ------------+----------------------------------- Total | 75 100.00 Frequencies for classification variable in enfrep20170920 dataset : Classificat | ion | Freq. Percent Cum. ------------+----------------------------------- Class I | 5 6.67 6.67 Class II | 65 86.67 93.33 Class III | 5 6.67 100.00 ------------+----------------------------------- Total | 75 100.00 Frequencies for productdescription variable in enfrep20170920 dataset : Product Description | Freq. Percent Cum. ----------------------------------------+----------------------------------- Homestyle 9111 block checked.; Keep .. | 1 1.33 1.33 AMLODIPINE BESYLATE TABLET, USP, 10 m.. | 1 1.33 2.67 ANDROPHARM M1 ALPHA (Methyl-1-Etiocho.. | 1 1.33 4.00 ANDROPHARM STEN Z (2, 17a-Dimethyl-17.. | 1 1.33 5.33 Apheresis Platelets, Leukocytes Reduced | 1 1.33 6.67 B-Complex, 30 mL vials, Rx only, Bell.. | 1 1.33 8.00 BD Needle 22GA 1-1/2in SafetyGlide(TM.. | 1 1.33 9.33 Baxter Amia Automated Peritoneal Dial.. | 1 1.33 10.67 BevaDex (bevacizumab) 0.06mL Prefille.. | 1 1.33 12.00 Bevacizumab Prefilled 30g and 31 gram.. | 1 1.33 13.33 Breaded Fish with Vera Cruz Sauce; I.. | 1 1.33 14.67 Calcium chloride 10%, 10 mL vials, Rx.. | 1 1.33 16.00 Cell Marque, Glypican-3 (1G12 Mab), 7.. | 1 1.33 17.33 Cell Marque, MSH6 (44 Mab.), 7 mL, RE.. | 1 1.33 18.67 Cell Marque, Microphthalmia Transcrip.. | 1 1.33 20.00 Cell Marque, Napsin A (MRQ-60 Mab.), .. | 1 1.33 21.33 Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL.. | 1 1.33 22.67 Cell Marque, Podoplanin (D2-40 Mab), .. | 1 1.33 24.00 Cell Marque, SOX-10 (Polyclonal), 7 m.. | 1 1.33 25.33 Doctor Manzanilla Allergy & Decongest.. | 1 1.33 26.67 Doctor Manzanilla Cough & Cold (diphe.. | 1 1.33 28.00 FFR Link-FFR Signal Processing Module.. | 1 1.33 29.33 Firebird NXG Spinal Fixation System D.. | 1 1.33 30.67 Fluorescein Sodium, 5mL vials, Rx onl.. | 1 1.33 32.00 Fujifilm Endoscope Model ED-530XT .. | 1 1.33 33.33 Fujifilm Endoscope Models ED-25.. | 1 1.33 34.67 G.A.C 25/100/250mg, 30 mL Vials, Rx o.. | 1 1.33 36.00 Herga foot switch, model 6289-WS, a c.. | 1 1.33 37.33 Hydrocodone Bitartrate and Acetaminop.. | 1 1.33 38.67 Java Monster Loco Moca Coffee & Energ.. | 1 1.33 40.00 L-Glutamine 100mg, 30 mL vials, Rx on.. | 1 1.33 41.33 Leader Liquid Multivitamin Supplement.. | 1 1.33 42.67 Leader Liquid Vitamin D Supplement fo.. | 1 1.33 44.00 Lidocaine Ophthalmic Gel 3.5%, 15mL b.. | 1 1.33 45.33 MIC 25/50/50, 30mL vials, Rx only, Be.. | 1 1.33 46.67 Magnesium Chloride 200mg, 30m L vials.. | 1 1.33 48.00 Major CertaVite Liquid, 8 oz. (236 mL.. | 1 1.33 49.33 Major D-Vita Drops, 1 2/3 oz (50 mL) .. | 1 1.33 50.67 Major Ferrous Drops, 1 2/3 oz (50 mL).. | 1 1.33 52.00 Major Poly-Vita Drops with Iron, 1 2.. | 1 1.33 53.33 Major Poly-Vita Drops, 1 2/3 oz (50 .. | 1 1.33 54.67 Major Tri-Vita Drops, 1 2/3 oz (50 mL.. | 1 1.33 56.00 Makoplasty Partial Knee Application (.. | 1 1.33 57.33 Mannitol 20%, 10 mL vials, Rx only, B.. | 1 1.33 58.67 Methylcobalamin 10mg, (10mg/ml), 30 m.. | 1 1.33 60.00 Methylcobalamin 10mg, (1mg/ml), 30 mL.. | 1 1.33 61.33 New Kopi Jantan Tradisional Natural H.. | 1 1.33 62.67 Ninjacof (Chlophedianol HCL 12.5 mg a.. | 1 1.33 64.00 Ninjacof-A (Acetaminophen 160 mg, Chl.. | 1 1.33 65.33 PF-Glutathione 200mg/ml, 30 mL vials,.. | 1 1.33 66.67 Paroxetine tablets USP, 30mg, 30-coun.. | 1 1.33 68.00 Phentermine, USP Capsules, 15 mg, 30 .. | 1 1.33 69.33 Phenylephrine2.5%/Tropicamide 1% Opht.. | 1 1.33 70.67 Pooled Cryoprecipitated AHF | 1 1.33 72.00 Rugby Calcionate Syrup, One Pint (47.. | 1 1.33 73.33 Rugby Cerovite Liquid, 8 oz. 236ML | 1 1.33 74.67 Rugby D 3 Vitamin Liquid, 400 IUI/1 m.. | 1 1.33 76.00 Rugby Fer-iron Liquid, 1 and 2/3 oz... | 1 1.33 77.33 Rugby Ferrous Sulfate Liquid One Pint.. | 1 1.33 78.67 Rugby Liquid Vitamin C Supplement, 4 .. | 1 1.33 80.00 Rugby Polyvitamin Liquid with Iron, 1.. | 1 1.33 81.33 Rugby Polyvitamin Liquid, 1 2/3 oz (5.. | 1 1.33 82.67 Rugby Tri-vitamin Liquid, 1 2/3 oz (5.. | 1 1.33 84.00 Sekisui Diagnostics Sekure Chemistry .. | 1 1.33 85.33 Skintact Electrode for Defibrillation.. | 1 1.33 86.67 Sodium Bicarbonate 8.4%, 10 mL vials,.. | 1 1.33 88.00 Spectra-System/Legacy Guided Surgery .. | 1 1.33 89.33 Super Panther 7K Capsules 1250 mg ble.. | 1 1.33 90.67 Toshiba Medical Radrex - i Digital Ra.. | 1 1.33 92.00 Total Hip Application (THA) Produ.. | 1 1.33 93.33 Vitamin A&D Ointment (petroleum 93.5%.. | 1 1.33 94.67 Wegmans Assorted Muffins 4-Pack-18 oz.. | 1 1.33 96.00 X-Laser Laser Light Show projector mo.. | 1 1.33 97.33 Zlotoklos brand Ciastka maslane w cze.. | 1 1.33 98.67 eMAG System, Ref 418591 It is an I.. | 1 1.33 100.00 ----------------------------------------+----------------------------------- Total | 75 100.00 Frequencies for productquantity variable in enfrep20170920 dataset : Product Quantity | Freq. Percent Cum. --------------------------------+----------------------------------- | 1 1.33 1.33 1,249,200 units | 1 1.33 2.67 1,728 units | 1 1.33 4.00 10 | 1 1.33 5.33 10 vials | 1 1.33 6.67 10,074 units | 1 1.33 8.00 105,628 units | 1 1.33 9.33 113,829 units | 1 1.33 10.67 117,098 units | 1 1.33 12.00 1212 bottles | 1 1.33 13.33 1250 bottles | 1 1.33 14.67 13 | 1 1.33 16.00 132 cases (18 shells per case) | 1 1.33 17.33 140 | 1 1.33 18.67 15 US | 1 1.33 20.00 150 bottles | 1 1.33 21.33 164,700 units | 1 1.33 22.67 2 units | 1 1.33 24.00 2,334 syringes | 1 1.33 25.33 20 vials | 1 1.33 26.67 200 syringes | 1 1.33 28.00 211 bottles; 339 boxes | 1 1.33 29.33 24 bottles | 2 2.67 32.00 2520 pcs | 1 1.33 33.33 260 manuals in total | 2 2.67 36.00 27,011 units | 1 1.33 37.33 27,447 units | 1 1.33 38.67 27,735 units | 1 1.33 40.00 291 (US) and 66 (OUS) | 1 1.33 41.33 3 | 2 2.67 44.00 3 vials | 1 1.33 45.33 3,840 units | 1 1.33 46.67 30 vials | 1 1.33 48.00 30,782 units | 1 1.33 49.33 3084 bottles | 1 1.33 50.67 320 units | 1 1.33 52.00 33 | 1 1.33 53.33 33,390 units | 1 1.33 54.67 34,280 units | 1 1.33 56.00 349 (US) and 78 (OUS) | 1 1.33 57.33 35 bottles | 1 1.33 58.67 37 | 1 1.33 60.00 4 | 1 1.33 61.33 4 units | 1 1.33 62.67 4149 bottles | 1 1.33 64.00 44800 bottles | 1 1.33 65.33 45 vials | 1 1.33 66.67 462 cases, 144 packets per case | 1 1.33 68.00 5 | 1 1.33 69.33 5 vials | 4 5.33 74.67 5,771 units | 1 1.33 76.00 52,897 units | 1 1.33 77.33 6 bottles | 2 2.67 80.00 6 planers | 1 1.33 81.33 6,250 packets | 1 1.33 82.67 61,262 units | 1 1.33 84.00 621 bottles | 1 1.33 85.33 63,005 units | 1 1.33 86.67 64 devices | 1 1.33 88.00 644 vials | 1 1.33 89.33 65,611 units | 1 1.33 90.67 7 vials | 1 1.33 92.00 7,965 cases | 1 1.33 93.33 8,249 units total | 1 1.33 94.67 82 vials | 1 1.33 96.00 830 | 1 1.33 97.33 84 units | 1 1.33 98.67 8792 cases | 1 1.33 100.00 --------------------------------+----------------------------------- Total | 75 100.00 Frequencies for reasonforrecall variable in enfrep20170920 dataset : Reason for Recall | Freq. Percent Cum. ----------------------------------------+----------------------------------- which required a reboot and loss of .. | 1 1.33 1.33 4-pack may contain banana nut muffin .. | 1 1.33 2.67 A delay in transit may have contribut.. | 7 9.33 12.00 After the firm received a consumer co.. | 1 1.33 13.33 Blood components, not manufactured ac.. | 1 1.33 14.67 CGMP Deviations: Recall initiated as .. | 2 2.67 17.33 Certain lots of the defibrillation el.. | 1 1.33 18.67 Complaints were received reporting th.. | 1 1.33 20.00 Failed Impurities/Degradation Specifi.. | 1 1.33 21.33 Failure to comply with performance st.. | 1 1.33 22.67 Fujifilm is conducting a corrective a.. | 1 1.33 24.00 Fujifilm is reporting a corrective ac.. | 1 1.33 25.33 Internal label verification found tha.. | 1 1.33 26.67 Labeling Mixup; the individual A&D oi.. | 1 1.33 28.00 Labeling: Not Elsewhere Classified; p.. | 1 1.33 29.33 Lack of Assurance of Sterility. | 16 21.33 50.67 Marketed without an Approved NDA/ANDA.. | 1 1.33 52.00 Marketed without an approved NDA/ANDA.. | 1 1.33 53.33 Marketed without an approved NDA/ANDA.. | 2 2.67 56.00 Microbial contamination of Non-steril.. | 2 2.67 58.67 PRESENCE OF FOREIGN TABLETS/CAPSULES:.. | 1 1.33 60.00 Platelet products, stored at an unacc.. | 1 1.33 61.33 Presence of Foreign tablets/capsules:.. | 1 1.33 62.67 Presence of loose polypropylene forei.. | 1 1.33 64.00 Presence of undeclared milk: the prod.. | 1 1.33 65.33 Product was distributed without going.. | 1 1.33 66.67 Reagent carryover from Sekisui ACTH w.. | 1 1.33 68.00 Software discrepancy of not showing a.. | 2 2.67 70.67 Some anomalies have been identified d.. | 1 1.33 72.00 The device history record (DHR) was m.. | 1 1.33 73.33 The distribution firms Leader Brand, .. | 17 22.67 96.00 The firm received increased customer .. | 1 1.33 97.33 The inside diameter of the 2.3mm smal.. | 1 1.33 98.67 The plastic core of the Decorticating.. | 1 1.33 100.00 ----------------------------------------+----------------------------------- Total | 75 100.00 Frequencies for centerclassificationdate variable in enfrep20170920 dataset : Center | Classificat | ion Date | Freq. Percent Cum. ------------+----------------------------------- 09/11/2017 | 7 9.33 9.33 09/12/2017 | 61 81.33 90.67 09/13/2017 | 4 5.33 96.00 09/14/2017 | 3 4.00 100.00 ------------+----------------------------------- Total | 75 100.00 Frequencies for terminationdate variable in enfrep20170920 dataset : Termination | Date | Freq. Percent Cum. ------------+----------------------------------- | 72 96.00 96.00 09/12/2017 | 2 2.67 98.67 09/14/2017 | 1 1.33 100.00 ------------+----------------------------------- Total | 75 100.00 Frequencies for codeinfo variable in enfrep20170920 dataset : Code Info | Freq. Percent Cum. ----------------------------------------+----------------------------------- 06.2017, 10.2017 | 1 1.33 1.33 All Date Codes | 1 1.33 2.67 All Lot codes | 2 2.67 5.33 All lots | 1 1.33 6.67 All lots remaining within expiry. | 2 2.67 9.33 Batch 0365, Lot F1728BF 0 | 1 1.33 10.67 Batch 47262-2, 47262-3, exp 8/31/2017.. | 1 1.33 12.00 For Manual Code 202B1259902B, 140417-.. | 1 1.33 13.33 Item # 9111; manufactured 7-17-2017 | 1 1.33 14.67 LLS projectors | 1 1.33 16.00 Leader Liquid Multivitamin Supplemen.. | 1 1.33 17.33 Leader Liquid Vitamin D Supplement fo.. | 1 1.33 18.67 Lot #203013-TD26 | 1 1.33 20.00 Lot #: 070617GL, Exp. 1/6/18 | 1 1.33 21.33 Lot #: 070717MC, Exp. 1/7/18 | 1 1.33 22.67 Lot #: 070717ML, Exp. 1/7/18 | 1 1.33 24.00 Lot #: 071217CC, Exp. 10/12/18 | 1 1.33 25.33 Lot #: 071217GAC, 1/12/18 | 1 1.33 26.67 Lot #: 08152017, Exp. 11/15/17 | 1 1.33 28.00 Lot #: 3141201, Exp. 9/13/17; 3146966.. | 1 1.33 29.33 Lot #: 6142626, Exp 09/19 | 1 1.33 30.67 Lot #: BPBC3080517, Exp. 2/5/18 | 1 1.33 32.00 Lot #: BPFS41717, Exp. 4/1/18 | 1 1.33 33.33 Lot #: BPLG08517, Exp. 2/5/18 | 1 1.33 34.67 Lot #: BPLG3508717, Exp. 11/7/17 | 1 1.33 36.00 Lot #: BPMC08517, Exp. 2/5/18 | 1 1.33 37.33 Lot #: BPMC30072917, Exp. 1/29/18 | 1 1.33 38.67 Lot #: BPMIC30072917, Exp. 1/29/18 | 1 1.33 40.00 Lot #: BPPTC08717, Exp. 11/7/17 | 1 1.33 41.33 Lot #: BPSB8408717, Exp. 11/7/17 | 1 1.33 42.67 Lot #: Z701133, Exp 03/19 | 1 1.33 44.00 Lot 65249, Sequence Number HE G-HKRev.. | 1 1.33 45.33 Lot Number: A-K-8383 | 1 1.33 46.67 Lot Numbers: 6211579, 6271695, 615476.. | 1 1.33 48.00 Lot numbers: H16G28107, H16H01086, H.. | 1 1.33 49.33 Lot/Batch No. (Exp Date): SPM01975 (0.. | 1 1.33 50.67 Lot: 200N1601 Exp. 11/2018 | 1 1.33 52.00 Lot: 201NA1601 Exp. 11/2018 | 1 1.33 53.33 Lot: 23221701, Exp. 05/19 | 2 2.67 56.00 Lot: 494700 Exp. 10/2018 | 1 1.33 57.33 Major CertaVite Liquid, 8 oz. (236 mL.. | 1 1.33 58.67 Major D-Vita Drops,1 2/3 oz (50 mL), .. | 1 1.33 60.00 Major Ferrous Drops,1 2/3 oz (50 mL),.. | 1 1.33 61.33 Major Poly-Vita Drops with Iron,1 2/.. | 1 1.33 62.67 Major Poly-Vita Drops,1 2/3 oz (50 .. | 1 1.33 64.00 Major Tri-Vita Drops,1 2/3 oz (50 mL).. | 1 1.33 65.33 Model Number DF59N (lot numbers 41219.. | 1 1.33 66.67 Product Code PA0796, Lot No. 47793, E.. | 1 1.33 68.00 Product Code PA0800, Lot No. 46232, E.. | 1 1.33 69.33 Product Code PA0803, Lot No. 46524, E.. | 1 1.33 70.67 Product Code PA0804, Lot No. 45973, E.. | 1 1.33 72.00 Product Code PA0805, Lot No. 46349, E.. | 1 1.33 73.33 Product Code PA0808, Lot No. 47795, E.. | 1 1.33 74.67 Product Code PA0813, Lot No. 47800, .. | 1 1.33 76.00 Rugby Cerovite Liquid, 236ML, UPC Nu.. | 1 1.33 77.33 Rugby D 3 Vitamin Liquid, 400 IUI/1 m.. | 1 1.33 78.67 Rugby Fer-iron Liquid, 1 and 2/3 oz.,.. | 1 1.33 80.00 Rugby Ferrous Sulfate Liquid,One Pint.. | 1 1.33 81.33 Rugby Liquid Vitamin C Supplement, 4 .. | 1 1.33 82.67 Rugby Polyvitamin Liquid with Iron, 1.. | 1 1.33 84.00 Rugby Polyvitamin Liquid, 1 2/3 oz (5.. | 1 1.33 85.33 Rugby Tri-vitamin Liquid, 1 2/3 oz (5.. | 1 1.33 86.67 Serial No. W8B1572022 | 1 1.33 88.00 Serial Numbers - IM03001, IM03002, IM.. | 1 1.33 89.33 Serial numbers for ROSA devices with .. | 1 1.33 90.67 UPC 557205060083 ,Exp 5/24/18 | 1 1.33 92.00 UPC Number: 0 05362 77085 1, All U.. | 1 1.33 93.33 W036517547314; W036517547313 (Triple .. | 1 1.33 94.67 W239617038945; W239617022505 | 1 1.33 96.00 a) RO846356 Exp. 8/28/2020; b) RO2468.. | 1 1.33 97.33 lot codes: 08617, 10417, 11717, 12917.. | 1 1.33 98.67 will be entered. | 1 1.33 100.00 ----------------------------------------+----------------------------------- Total | 75 100.00 Frequencies for recallinitiationdate variable in enfrep20170920 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 09mar2015 | 2 2.67 2.67 20jan2016 | 1 1.33 4.00 20mar2017 | 1 1.33 5.33 23mar2017 | 1 1.33 6.67 10apr2017 | 1 1.33 8.00 05may2017 | 1 1.33 9.33 15may2017 | 1 1.33 10.67 06jun2017 | 2 2.67 13.33 13jun2017 | 1 1.33 14.67 19jun2017 | 1 1.33 16.00 26jun2017 | 1 1.33 17.33 14jul2017 | 7 9.33 26.67 17jul2017 | 1 1.33 28.00 20jul2017 | 1 1.33 29.33 21jul2017 | 1 1.33 30.67 24jul2017 | 1 1.33 32.00 02aug2017 | 18 24.00 56.00 03aug2017 | 1 1.33 57.33 07aug2017 | 2 2.67 60.00 08aug2017 | 1 1.33 61.33 09aug2017 | 1 1.33 62.67 15aug2017 | 16 21.33 84.00 17aug2017 | 2 2.67 86.67 18aug2017 | 1 1.33 88.00 22aug2017 | 2 2.67 90.67 28aug2017 | 2 2.67 93.33 30aug2017 | 2 2.67 96.00 01sep2017 | 1 1.33 97.33 05sep2017 | 2 2.67 100.00 ------------+----------------------------------- Total | 75 100.00 Frequencies for recallinitiationdatestr variable in enfrep20170920 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 01/20/2016 | 1 1.33 1.33 03/09/2015 | 2 2.67 4.00 03/20/2017 | 1 1.33 5.33 03/23/2017 | 1 1.33 6.67 04/10/2017 | 1 1.33 8.00 05/05/2017 | 1 1.33 9.33 05/15/2017 | 1 1.33 10.67 06/06/2017 | 2 2.67 13.33 06/13/2017 | 1 1.33 14.67 06/19/2017 | 1 1.33 16.00 06/26/2017 | 1 1.33 17.33 07/14/2017 | 7 9.33 26.67 07/17/2017 | 1 1.33 28.00 07/20/2017 | 1 1.33 29.33 07/21/2017 | 1 1.33 30.67 07/24/2017 | 1 1.33 32.00 08/02/2017 | 18 24.00 56.00 08/03/2017 | 1 1.33 57.33 08/07/2017 | 2 2.67 60.00 08/08/2017 | 1 1.33 61.33 08/09/2017 | 1 1.33 62.67 08/15/2017 | 16 21.33 84.00 08/17/2017 | 2 2.67 86.67 08/18/2017 | 1 1.33 88.00 08/22/2017 | 2 2.67 90.67 08/28/2017 | 2 2.67 93.33 08/30/2017 | 2 2.67 96.00 09/01/2017 | 1 1.33 97.33 09/05/2017 | 2 2.67 100.00 ------------+----------------------------------- Total | 75 100.00 Frequencies for reportdate variable in enfrep20170920 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 20sep2017 | 75 100.00 100.00 ------------+----------------------------------- Total | 75 100.00 Frequencies for reportdatestr variable in enfrep20170920 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 09/20/2017 | 75 100.00 100.00 ------------+----------------------------------- Total | 75 100.00 by Jean Roth , jroth@nber.org , 21 Sep 2017