logiover/fda-data-scraper-sample-data huggingface dataset:
FDA recall D-1154-2017 (Class II, Drugs) — status: Terminated
Recalling firm: Bella Pharmaceuticals, Inc.
Address: 3101 W Devon Ave , Chicago, IL 60659-1407, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Quantity: 5 vials
Reason for recall: Lack of Assurance of Sterility.
Distribution: Nationwide within USA
Code info: Lot #: BPLG08517, Exp. 2/5/18
Recall initiated: 20170815; classified: 20170912; reported: 20170920
Terminated: 20180423
FDA recall D-0563-2018 (Class I, Drugs) — status: Terminated
Recalling firm: A&H Focal Inc.
Address: 119 Linwood Ave , Staten Island, NY 10305-4445, United States
Recall type: Voluntary: Firm initiated; initial notification: Press Release
Product: Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
Quantity: unknown
Reason for recall: Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Distribution: NY and NJ through six retail stores named "Asian Food Markets"
Code info: All Lots
Recall initiated: 20170307; classified: 20180228; reported: 20180207
Terminated: 20190614
FDA recall D-282-2013 (Class II, Drugs) — status: Terminated
Recalling firm: Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Address: 550 Technology Park Ste 1008 , Lake Mary, FL 32746-7131, United States
Recall type: Voluntary: Firm initiated; initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product: Trimix  Customs Injectable  Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746
Quantity: 61 vials (5 mL and 10 mL vials)
Reason for recall: Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this  compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Distribution: CO, GA, MI, and Puerto Rico
Code info: ALL Lots
Recall initiated: 20130417; classified: 20130423; reported: 20130501
Terminated: 20170419
FDA recall D-1152-2017 (Class II, Drugs) — status: Terminated
Recalling firm: Bella Pharmaceuticals, Inc.
Address: 3101 W Devon Ave , Chicago, IL 60659-1407, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Quantity: 7 vials
Reason for recall: Lack of Assurance of Sterility.
Distribution: Nationwide within USA
Code info: Lot #: BPMC30072917, Exp. 1/29/18
Recall initiated: 20170815; classified: 20170912; reported: 20170920
Terminated: 20180423
FDA recall D-0337-2017 (Class II, Drugs) — status: Terminated
Recalling firm: Wells Pharmacy Network LLC
Address: 1210 SW 33rd Ave , Ocala, FL 34474-2853, United States
Recall type: Voluntary: Firm initiated; initial notification: Press Release
Product: Alprostadil 20 mcg/mL Injectable, a) 5 mL  and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
Quantity: a) 24 vials, b) 91 vials
Reason for recall: Lack of Assurance of Sterility
Distribution: Nationwide
Code info: All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry.     a) Known lot code: 03312016@6  b) Known lot code: 04222016@8, 15202016@85, 06302016@4, 08012016@32
Recall initiated: 20160921; classified: 20170104; reported: 20170111
Terminated: 20210702
FDA recall D-1849-2019 (Class II, Drugs) — status: Terminated
Recalling firm: Pacifico National, Inc. dba AmEx Pharmacy
Address: 1515 Elizabeth St Ste J , Melbourne, FL 32901-3000, United States
Recall type: Voluntary: Firm initiated; initial notification: Press Release
Product: Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901
Reason for recall: Lack of assurance of sterility.
Distribution: Continental U.S. and Puerto Rico
Code info: All lots remaining within expiry.
Recall initiated: 20190830; classified: 20190910; reported: 20190918
Terminated: 20201008
FDA recall D-1110-2019 (Class II, Drugs) — status: Terminated
Recalling firm: Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy
Address: 996 Nw Circle Blvd Ste 105 , Corvallis, OR 97330-1485, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: PAPAVERINE-PHENTOLAMINE-PGE1 17.44-0.64MG-5.8MCG/ML* INJECTABLE, 5 ml, Professional Compounding Pharmacy, 996 NW Circle Blvd. #105 Corvallis, OR 97330 .
Quantity: 1 prescription, 5ml injection
Reason for recall: Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Distribution: Dispensed in Oregon
Code info: Lot:13092018@44, distributed between 09-01-2018 to 02-20-2019.
Recall initiated: 20190221; classified: 20190409; reported: 20190417
Terminated: 20200723
FDA recall D-1842-2019 (Class III, Drugs) — status: Terminated
Recalling firm: Aurobindo Pharma USA Inc.
Address: 279 Princeton Hightstown Rd , East Windsor, NJ 08520-1401, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810  Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810  NDC 65862-053-99
Quantity: 2,352/1000 count bottles
Reason for recall: Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Distribution: Product was distributed nationwide by three major distributors who may have further distributed the product.
Code info: 05318054B, exp 3/2021
Recall initiated: 20190729; classified: 20190826; reported: 20190904
Terminated: 20211028
Drug details: brand_name: SIMVASTATIN
generic_name: SIMVASTATIN
manufacturer_name: Aurobindo Pharma Limited
product_type: HUMAN PRESCRIPTION DRUG
route: ORAL
substance_name: SIMVASTATIN
pharm_class_epc: HMG-CoA Reductase Inhibitor [EPC]
pharm_class_moa: Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
FDA recall D-1746-2019 (Class II, Drugs) — status: Terminated
Recalling firm: Infusion Options, Inc.
Address: 5924 13th Ave , Brooklyn, NY 11219-4934, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233
Reason for recall: Lack of Assurance of Sterility
Distribution: NY only
Code info: All lots within expiry
Recall initiated: 20190612; classified: 20190815; reported: 20190821
Terminated: 20250321
FDA recall D-759-2014 (Class II, Drugs) — status: Terminated
Recalling firm: Novartis Consumer Health
Address: 10401 Hwy 6 , Lincoln, NE 68517-9626, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga , ON, UPC 0 58478 05103 1.    Also packaged under foreign labels:   Theraflu Extra Cold and Flu powder packets, Lemon flavor, 10-count packets per box, UPC 4 607045 191395 (Russia and Former Soviet Union product); Theraflu Nighttime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, UPC 8 806536 013925 (Korea product);
Reason for recall: Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Distribution: Nationwide, Mexico, Russia, Korea, Panama, China, and Canada.
Code info: Lot #: 10113888, Exp 5/31/2013; 10118944, Exp 6/30/2013; 10120024, Exp 9/30/2013; 10124381, Exp 10/31/2013.    Russia product: 10112623, 10112625, 10112627, 10112629, 10112631, 10112633, Exp 5/31/2013; 10116051, 10116053, 10116055, 10116057, 10116059, 10116061,10117302, 10117304, Exp 7/31/2013; 10119732, 10119735, Exp 9/30/2013; 10124276, 10124281, 10125922, 10126539, 10126540, 10126541, 10126542, 10126543, Exp 10/31/2013;     Korea product: 10112969, Exp 5/31/2013; 10116034, Exp 7/31/2013; 10120027, Exp 9/30/2013.
Recall initiated: 20130618; classified: 20140117; reported: 20140129
Terminated: 20141104
FDA recall D-1122-2020 (Class II, Drugs) — status: Terminated
Recalling firm: Herbal Doctor Remedies
Address: 497 Cumbre St , Monterey Park, CA 91754-2114, United States
Recall type: Voluntary: Firm initiated; initial notification: Other
Product: Edema Off, Distributed by Herbal Doctor Remedies Alhambra, CA 91801-7081 USA, 1(800) 600-0808
Reason for recall: CGMP Deviations: These products have been found to be misbranded as  unapproved new drugs
Distribution: Products are sold online within the United States and  internationally to the following countries: Australia, Canada, Israel, Italy, Japan, Norway, and United Kingdom
Code info: All lots within expiry
Recall initiated: 20200324; classified: 20200407; reported: 20200415
Terminated: 20240125
FDA recall D-0878-2023 (Class II, Drugs) — status: Terminated
Recalling firm: The Harvard Drug Group
Address: 341 Mason Rd , La Vergne, TN 37086-3606, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
Quantity: 3876 cartons
Reason for recall: Packaging defect: blister packaging inadequately sealed.
Distribution: Nationwide in the U.S.
Code info: Lot #: M04343, Exp. 04/2024
Recall initiated: 20230616; classified: 20230626; reported: 20230705
Terminated: 20240430
FDA recall D-0210-2023 (Class II, Drugs) — status: Terminated
Recalling firm: Pharmacy Innovations
Address: 2936 W 17th St , Erie, PA 16505-3929, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 200MG/ML (1ML NEBVL) INHALATION; GLUTATHIONE L REDUCED 220MG/ML (30ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (1ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED 500MG/ML (2ML VIAL) INJECTABLE; GLUTATHIONE L REDUCED-PF- 200MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Reason for recall: Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Distribution: Nationwide in the USA
Code info: t20221129@68 t20221025@32 t20221025@33 t20221114@27 t20221021@40 t20221116@36
Recall initiated: 20221222; classified: 20230126; reported: 20230201
Terminated: 20240731
FDA recall D-1060-2014 (Class II, Drugs) — status: Terminated
Recalling firm: Actavis Inc
Address: 400 Interpace Pkwy , Parsippany, NJ 07054-1120, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60 (60 count bottles)
Quantity: 6,540 bottles
Reason for recall: Failed Tablet/Capsule Specifications: Broken tablets
Distribution: Nationwide
Code info: Lot 668271A, Exp 11/14 and Lot 684119A Exp 01/2015
Recall initiated: 20130322; classified: 20140203; reported: 20140212
Terminated: 20150226
Drug details: brand_name: DICLOFENAC SODIUM AND MISOPROSTOL
generic_name: DICLOFENAC SODIUM AND MISOPROSTOL
manufacturer_name: Actavis Pharma, Inc.
product_type: HUMAN PRESCRIPTION DRUG
route: ORAL
substance_name: DICLOFENAC SODIUM, MISOPROSTOL
pharm_class_epc: Prostaglandin E1 Analog [EPC]
pharm_class_cs: Prostaglandins E, Synthetic [CS]
FDA recall D-0348-2025 (Class II, Drugs) — status: Ongoing
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Address: 750 Corporate Dr , Mahwah, NJ 07430-2009, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
Reason for recall: CGMP Deviations
Distribution: U.S. Nationwide
Code info: Lot #  17231980, ep.. date Aug-25 Amazon 17232044, ep.. date Aug-25 Walmart  17241436, ep.. date Jul-26 Amazon 17241437, ep.. date Jul-26 Amazon 17241455, ep.. date Jul-26 Amazon 17241456, ep.. date Aug-26 Amazon 17241457, ep.. date Aug-26 Amazon 17241892, ep.. date Oct-26 Amazon 17241893, ep.. date Oct-26 Amazon
Recall initiated: 20250313; classified: 20250408; reported: 20250416
Drug details: brand_name: CETIRIZINE HCL
generic_name: CETIRIZINE
manufacturer_name: GLENMARK THERAPEUTICS INC., USA
product_type: HUMAN OTC DRUG
route: ORAL
substance_name: CETIRIZINE HYDROCHLORIDE
FDA recall D-0680-2019 (Class I, Drugs) — status: Terminated
Recalling firm: King Bio Inc.
Address: 3 Westside Dr , Asheville, NC 28806-2846, United States
Recall type: Voluntary: Firm initiated; initial notification: Press Release
Product: Dr. King's SafeCare Rx Lonely Mind & Body High Potency Homeopathic Formula for Professional Use Only, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside dr. Asheville, NC 28806 USA,  UPC 357955200024,  NDC 57955-2001-2
Quantity: 53 bottles
Reason for recall: Microbial contamination
Distribution: U.S.A. Nationwide, Canada, and Australia.
Code info: Lots: 010518H Exp. 01/20; 040616N Exp. 04/19
Recall initiated: 20180720; classified: 20190308; reported: 20190320
Terminated: 20220119
FDA recall D-1074-2017 (Class II, Drugs) — status: Terminated
Recalling firm: Cantrell Drug Company
Address: 7321 Cantrell Rd , Little Rock, AR 72207-4144, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12
Quantity: 46078 syringes
Reason for recall: Lack of Sterility Assurance.
Distribution: Nationwide within the US
Code info: Lot #: 9556, BUD: 7/26/2017; 9566, BUD: 7/30/2017; 9584, BUD; 8/1/2017; 9613, BUD: 8/6/2017; 9656, BUD: 8/14/2017; 9798, BUD: 9/11/2017; 9812, BUD: 8/31/2017; 9819, BUD: 9/16/2017; 9836, BUD: 9/17/2017; 9944, BUD: 10/3/2017; 10158, 10493, 10565, BUD: 10/30/2017
Recall initiated: 20170714; classified: 20170809; reported: 20170816
Terminated: 20200916
FDA recall D-1286-2014 (Class III, Drugs) — status: Terminated
Recalling firm: Aaron Industries Inc
Address: 11865 Alameda St , Lynwood, CA 90262-4022, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength, Cough Cold, Dextromethorphan HBr, USP, 10 mg (Cough Suppressant) , Guaifenesin, USP, 200 mg  (Expectorant), 4, 8 fl oz bottles , OTC only, labeled as A) CareOne 8 fl oz bottle, Distributed by American Sales Company, Lancaster, NY 14086, UPC 341520339677, B) Our Family 4 fl oz bottle, Distributed by Nash Finch Company, NFC Brands, MPLS, MN 55435, UPC 070253579523, C) Premier Value 4, 8 fl oz bottle, Distributed by Chain Drug Consortium, LLC., Boca Raton, FL 33431, 4 fl oz UPC 840986024719;  8 fl oz UPC 840986024726, NDC 68016-177-XX,  D) Rexall  4 fl oz bottle, Packaged for Dolencorp, LLC, Goodlettsville, TN 37072, UPC 715256714044, E) Safeway  4 fl oz, Distributed by Safeway INC, Pleasanton, CA 94566-0009, UPC 321130763581; F) Select Brand 4, 8 fl oz, Distributed by Select Brand Distributers, Pine Bluff, AR 71603, 4 fl oz UPC 015127024303; 8 fl oz UPC 015127024310.
Quantity: 108,792 bottles
Reason for recall: Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Distribution: Nationwide
Code info: Lot #: 73762, 80030, 82053, 83032, 73768, 76414, 78222, 78441, 140423, 140494, 142396,145460,145959, 73831, 73832, 78440, 79819, 82606, 80969, 140530, 142413, 145461, 74163; Exp 06/14     Lot #:148820, 149396, 149995, 150208, 150422, 150599, 151023, 151071,151337, 148931,151072. ; Exp 08/15
Recall initiated: 20140411; classified: 20140429; reported: 20140507
Terminated: 20150213
FDA recall D-1135-2016 (Class II, Drugs) — status: Terminated
Recalling firm: Reliable Rexall-A Compounding Pharmacy
Address: 801 Irving St , San Francisco, CA 94122-2310, United States
Recall type: Voluntary: Firm initiated; initial notification: Press Release
Product: All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
Reason for recall: Lack of Processing Controls
Distribution: U.S. Including: CA, HI, NM
Code info: All lots compounded between 03/24/2015 and 03/24/2016 and within expiry.
Recall initiated: 20160325; classified: 20160706; reported: 20160713
Terminated: 20170410