logiover/fda-data-scraper-sample-data huggingface dataset:
FDA recall D-321-2016 (Class II, Drugs) — status: Terminated
Recalling firm: Kalman Health & Wellness, Inc. dba Essential Wellness Pharma
Address: 4625 N University St , Peoria, IL 61614-5828, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Progesterone 100 mg/mL in Corn Oil Injection, 2 mL vials, Rx only, Essential Wellness PHARMACY, 4625 N. University, Peoria, IL 61614.
Quantity: 1 vial
Reason for recall: Lack of Assurance of Sterility:  A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Distribution: Nationwide
Code info: Lot #: 072915, Exp 10/29/2015
Recall initiated: 20150903; classified: 20151117; reported: 20151125
Terminated: 20171229
FDA recall D-0080-2021 (Class II, Drugs) — status: Ongoing
Recalling firm: Albek De Mexico S.A. De C.V.
Address: Oriente Cuatro No. 11 Nuevo , San Juan Del Rio, N/A N/A, Mexico
Recall type: Voluntary: Firm initiated; initial notification: Press Release
Product: Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 fl oz / 237 mL bottle, Distributed By: Greenbrier International, Inc. 500 Volvo Parkway, Chesapeake, VA 23320. Made in Mexico.UPC 639277928610
Quantity: 27,000 bottles
Reason for recall: CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Distribution: USA Nationwide
Code info: 1931102AL
Recall initiated: 20200730; classified: 20201117; reported: 20201125
FDA recall D-0115-2026 (Class II, Drugs) — status: Ongoing
Recalling firm: ProRx LLC
Address: 619 Jeffers Cir , Exton, PA 19341-2540, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341.  NDC:  84139-225-04
Quantity: 8,400 vials
Reason for recall: Lack of Assurance of Sterility
Distribution: TX and UT
Code info: Lot, Best Use Date (BUD):  Lot PRORX050925-1, BUD November 4, 2025;  Lot ProRx051425-5, BUD November 10, 2025; Lot ProRx051425-6, BUD November 10, 2025
Recall initiated: 20251015; classified: 20251027; reported: 20251105
FDA recall D-1285-2020 (Class II, Drugs) — status: Terminated
Recalling firm: Teva Pharmaceuticals USA
Address: 400 Interpace Pkwy , Parsippany, NJ 07054-1120, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed Amphetamine Salts Product), 5 mg, 100 count bottles, Rx Only, Teva Pharmaceuticals USA, INC. North Wales, PA 19454, NDC 0555-0971-02
Quantity: 33,280 bottles
Reason for recall: Some bottles may contain mixed strengths of the product.
Distribution: Nationwide within the United State and Puerto Rico.
Code info: Lot #: 42614718, Exp. date 02/2021
Recall initiated: 20200522; classified: 20200604; reported: 20200610
Terminated: 20210525
Drug details: brand_name: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
generic_name: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
manufacturer_name: Teva Pharmaceuticals USA, Inc.
product_type: HUMAN PRESCRIPTION DRUG
route: ORAL
substance_name: AMPHETAMINE ASPARTATE MONOHYDRATE, AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, DEXTROAMPHETAMINE SULFATE
FDA recall D-0623-2022 (Class II, Drugs) — status: Terminated
Recalling firm: Perrigo Company PLC
Address: 515 Eastern Ave , Allegan, MI 49010-9070, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10
Quantity: 1,560 bottles
Reason for recall: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Distribution: Nationwide in the USA
Code info: Batch: 1BK0964, Exp 01/31/2023
Recall initiated: 20211026; classified: 20220223; reported: 20220302
Terminated: 20230929
Drug details: brand_name: EQUALINE NASAL
generic_name: OXYMETAZOLINE HCL
manufacturer_name: United Natural Foods, Inc. dba UNFI
product_type: HUMAN OTC DRUG
route: NASAL
substance_name: OXYMETAZOLINE HYDROCHLORIDE
FDA recall D-1398-2016 (Class II, Drugs) — status: Terminated
Recalling firm: Pharmedium Services, LLC
Address: 150 N Field Dr Ste 350 , Lake Forest, IL 60045-2506, United States
Recall type: Voluntary: Firm initiated; initial notification: E-Mail
Product: 2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48
Quantity: 940 bags
Reason for recall: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Distribution: Nationwide
Code info: Lot Number 160380168M , Exp. Date 5/8/2016 ;  Lot Number 160410137M , Exp. Date 5/11/2016 ;  Lot Number 160460150M , Exp. Date 5/16/2016 ;  Lot Number 160530279M , Exp. Date 5/23/2016 ;  Lot Number 160590185M , Exp. Date 5/29/2016 ;  Lot Number 160630160M , Exp. Date 6/2/2016 ;  Lot Number 160680179M , Exp. Date 6/7/2016 ;  Lot Number 160730238M , Exp. Date 6/12/2016 ;  Lot Number 160840215M , Exp. Date 6/23/2016 ;  Lot Number 160880193M , Exp. Date 6/27/2016 ;  Lot Number 160890187M , Exp. Date 6/28/2016 ;
Recall initiated: 20160505; classified: 20160716; reported: 20160727
Terminated: 20180306
FDA recall D-1443-2014 (Class III, Drugs) — status: Terminated
Recalling firm: Pfizer Inc.
Address: 235 East 42nd Street , New York, NY 10017-5703, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: VIRACEPT (R) (nelfinavir mesylate) Tablets, 625 mg, 120-count bottle, Rx only, Manufactured by: Agouron Pharmaceuticals, Inc. A Pfizer Company,  Distributed by: ViV Healthcare Company, Research Triangle Park, NC 27709  NDC 63010-027-70
Quantity: 1200  tablets
Reason for recall: Labeling: Incorrect or missing lot and or Exp Date: The bottles were labeled with an incorrect expiry date 11/2016.  The correct expiry date is 09/2016.
Distribution: Nationwide and Puerto Rico
Code info: Lot H45241, exp. 11/16
Recall initiated: 20140708; classified: 20140717; reported: 20140723
Terminated: 20150706
Drug details: brand_name: VIRACEPT
generic_name: NELFINAVIR MESYLATE
manufacturer_name: AGOURON
product_type: HUMAN PRESCRIPTION DRUG
route: ORAL
substance_name: NELFINAVIR MESYLATE
FDA recall D-0572-2024 (Class II, Drugs) — status: Ongoing
Recalling firm: Little Moon Essentials LLC
Address: 501 Old Griffin Rd , Dania Beach, FL 33004-2774, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Little Moon Essentials, Crampy Belly Rub (Camphor 1.1%), Packaged as a) 4 FL OZ (118ML) glass jar, UPC Code 6 73673 88260 2, NDC 70722-260-04; b) 2 FL OZ (59ML) glass jar, UPC Code 6 73673 88204 6, NDC 70722-260-02, Little Moon Essentials LLC Dania Beach, Fl 33004
Quantity: 788 glass jars
Reason for recall: CGMP deviations
Distribution: Nationwide USA and Ontario, Canada (2 retailers)
Code info: lot code No Expiration Date on product:  a) 224010,  b) 321260, 322260, 320280, 328080, 325021, 321121, 423010, 427110, 429120, 420220, 422140
Recall initiated: 20240620; classified: 20240702; reported: 20240710
FDA recall D-0194-2019 (Class II, Drugs) — status: Terminated
Recalling firm: Pharm D Solutions, LLC
Address: 1304 S Loop W , Houston, TX 77054-4010, United States
Recall type: Voluntary: Firm initiated; initial notification: Press Release
Product: Trimix QM10 Papaverine 30 mg/Phentolamine 4 mg/Atropine 1 mg/PGE 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1352-05
Quantity: 9 vials
Reason for recall: Lack of Assurance of Sterility
Distribution: Nationwide
Code info: Lot: 04262018:09 Discard by: 10/22/2018; 07022018:48 Discard by: 12/29/2018
Recall initiated: 20180910; classified: 20181101; reported: 20181107
Terminated: 20210205
FDA recall D-1066-2013 (Class II, Drugs) — status: Terminated
Recalling firm: AmeriSource Bergen
Address: 1300 Morris Dr , Chesterbrook, PA 19087-5559, United States
Recall type: Voluntary: Firm initiated; initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product: Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22
Quantity: 60 vials
Reason for recall: Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Distribution: Nationwide
Code info: Lot #s: 7800929, 7800931, Exp 02/15; 7800962, Exp 03/15
Recall initiated: 20130913; classified: 20130927; reported: 20131009
Terminated: 20141001
FDA recall D-1035-2017 (Class II, Drugs) — status: Terminated
Recalling firm: Apace KY LLC
Address: 12954 Fountain Run Rd , Fountain Run, KY 42133-7914, United States
Recall type: Voluntary: Firm initiated; initial notification: E-Mail
Product: Amantadine HCl Capsules, USP, 100 mg, Rx Only,  50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15
Quantity: 1,483 cartons
Reason for recall: Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Distribution: KY
Code info: Lot:  16710, exp 07/2018
Recall initiated: 20170619; classified: 20170731; reported: 20170809
Terminated: 20180504
FDA recall D-0429-2021 (Class II, Drugs) — status: Terminated
Recalling firm: Cardinal Health Inc.
Address: 7000 Cardinal Pl , Dublin, OH 43017-1091, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328
Quantity: 328 bottles
Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Distribution: FL, GA, SC
Code info: 78902-1
Recall initiated: 20210315; classified: 20210524; reported: 20210602
Terminated: 20240617
Drug details: brand_name: EDARBI
generic_name: AZILSARTAN KAMEDOXOMIL
manufacturer_name: Azurity Pharmaceuticals, Inc.
product_type: HUMAN PRESCRIPTION DRUG
route: ORAL
substance_name: AZILSARTAN KAMEDOXOMIL
FDA recall D-1519-2015 (Class II, Drugs) — status: Terminated
Recalling firm: The Compounding Pharmacy of America
Address: 6216 Highland Place Way Ste 101-A , Knoxville, TN 37919-4068, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: HCG 1,100 IU/ml Injection, Multi-Dose Vial, Sterile, Refrigerate The Compounding Pharmacy of America, Knoxville, TN
Quantity: 1558 ml total
Reason for recall: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Distribution: Nationwide
Code info: All lots distributed between November 2014 and May 2015;  05062015@32, 8/4/2015; 02272015@16, 5/28/2015; 03032015@33, 6/1/2015; 03042015@36, 6/2/2015; 03062015@43, 6/4/2015; 03092015@77, 6/7/2015; 03092015@92, 6/7/2015; 03132015@17, 11/2015; 03162015@23, 14/2015; 03172015@40, 5/2015; 03232015@39, 6/21/2015; 03242015@23, 6/22/2015; 03242015@29, 6/22/2015; 04162015@46, 7/15/2015; 04012015@8, 6/30/2015; 04062015@10, 7/5/2015; 04072015@17, 7/6/2015; 04142015@2, 7/13/2015; 04132015@34, 7/12/2015; 04202015@45, 7/19/2015; 04172015@63, 7/16/2015; 04272015@5, 7/26/2015; 05082015@44, 8/6/2015
Recall initiated: 20150602; classified: 20150915; reported: 20150923
Terminated: 20160210
FDA recall D-367-2014 (Class II, Drugs) — status: Terminated
Recalling firm: West-Ward Pharmaceutical Corp.
Address: 465 Industrial Way W , Eatontown, NJ 07724-2209, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Carisoprodol Tablets, USP 350 mg, Rx Only, 1000 tablets.  Dist by: West-ward Pharmaceutical Corp. Eatontown, NJ 07724. Mfd by: Shasun Chemicals and Drugs Limited, Unit II, R. S. Na 32, 33, 743 PIMS Rd, Periyakalepet, Pondicherry. 605014 INDIA. NDC 0143-9749-10.
Quantity: 20,534 bottles
Reason for recall: Presence of Foreign Substance; heavy metals (chromium, titanium etc) and inactive components of the product were visually observed during routine stability testing
Distribution: Nationwide
Code info: NDC 0143-9749-10  Lot: 1) 10BR001B, Exp Aug-2014  2) 10BR002B, Exp Aug-2014 3) 10BR003B Exp, Aug-2014 4) 10BR004B Exp, Aug-2014  5) 10BR005B Exp, Aug-2014 6) 10BR006B Exp, Aug-2014 7) 11BR001B Exp, Aug-2014 8) 11BR002B Exp, Jul-2015 9) 11BR003B Exp, Jul-2015  10) 11BR004B Exp, Jul-2015  11) 11BR005B Exp, Jul-2015 12) 11BR006B Exp, Jul-2015
Recall initiated: 20131107; classified: 20131216; reported: 20131225
Terminated: 20140814
FDA recall D-0179-2024 (Class II, Drugs) — status: Terminated
Recalling firm: CARDINAL HEALTHCARE
Address: 7200 Cardinal Pl W , Dublin, OH 43017-1094, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540.  NDC: 0781-3299-69
Quantity: 2 units
Reason for recall: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Distribution: Nationwide USA
Code info: Batch SAH06821A
Recall initiated: 20220126; classified: 20231226; reported: 20240103
Terminated: 20240929
Drug details: brand_name: ENOXAPARIN SODIUM
generic_name: ENOXAPARIN SODIUM
manufacturer_name: Sandoz Inc
product_type: HUMAN PRESCRIPTION DRUG
route: SUBCUTANEOUS
substance_name: ENOXAPARIN SODIUM
FDA recall D-1178-2018 (Class I, Drugs) — status: Terminated
Recalling firm: Westminster Pharmaceuticals LLC
Address: 1 & 2 154 Downing Street, Olive Branch, MS 38654, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04.
Quantity: Unknown
Reason for recall: Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.
Distribution: Nationwide in the USA and Puerto Rico
Code info: Lot #: 15617VP03, 15617VP01, 15617VP-02, Exp 7/31/2019;  15617VP06, 15617VP05, Exp 11/30/2019; 15617VP04, 15618004, 15618002, Exp 12/31/2019; 15618009, 15618008, Exp 2/29/2020; 15618011, Exp 3/31/2020.
Recall initiated: 20180803; classified: 20180907; reported: 20180829
Terminated: 20200603
FDA recall D-0176-2018 (Class II, Drugs) — status: Terminated
Recalling firm: KRS Global Biotechnology, Inc
Address: 791 Park of Commerce Blvd Ste 600 , Boca Raton, FL 33487-3633, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only, KRS Global Biotechnology, 791 Park of Commerce Blvd, Boca Raton, FL 33487.
Quantity: 2,239 vials
Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Distribution: Nationwide in the USA, Bermuda, and New Zealand
Code info: Lot: 08302017@11 BUD: 2/26/2018
Recall initiated: 20171116; classified: 20180108; reported: 20180117
Terminated: 20200511
FDA recall D-0296-2023 (Class II, Drugs) — status: Terminated
Recalling firm: Sentara Infusion Services
Address: 535 Independence Pkwy Ste 300 , Chesapeake, VA 23320-5176, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: HYDROMORPHONE (a) 1MG/ML IN NS,  50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx only, used with a Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320, NDC# 00409-2634-50
Quantity: 37 bags
Reason for recall: Lack of sterility assurance
Distribution: Dispensed to Patients Nationwide.
Code info: Beyond Use Date: December 24-31, 2022
Recall initiated: 20221227; classified: 20230215; reported: 20230222
Terminated: 20260220
FDA recall D-1744-2015 (Class II, Drugs) — status: Terminated
Recalling firm: The Compounding Pharmacy of America
Address: 6216 Highland Place Way Ste 101-A , Knoxville, TN 37919-4068, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: Testosterone 20 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Quantity: 24 pellets
Reason for recall: Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Distribution: Nationwide
Code info: All lots distributed between November 2014 and May 2015;  03032015@43, 8/30/2015
Recall initiated: 20150602; classified: 20150915; reported: 20150923
Terminated: 20160210
FDA recall D-518-2014 (Class II, Drugs) — status: Terminated
Recalling firm: Aidapak Services, LLC
Address: 14301 Se 1st St , Vancouver, WA 98684-3501, United States
Recall type: Voluntary: Firm initiated; initial notification: Telephone
Product: FAMOTIDINE Tablet, 20 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 16714036104
Quantity: 700 Tablets
Reason for recall: Labeling: Label Mixup; FAMOTIDINE Tablet, 20 mg may be potentially mislabeled as    CARVEDILOL PHOSPHATE ER, Capsule, 20 mg, NDC 00007337113, Pedigree: W003225, EXP: 6/17/2014;  DULoxetine HCl DR, Capsule, 20 mg, NDC 00002323560, Pedigree: W003506, EXP: 6/21/2014;  FAMOTIDINE, Tablet, 20 mg, NDC 16714036104, Pedigree: W003507, EXP: 6/21/2014;  MYCOPHENOLATE MOFETIL, Capsule, 250 mg, NDC 0037822500
Distribution: Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Code info: FAMOTIDINE Tablet, 20 mg has the following codes    Pedigree: W003226, EXP: 6/17/2014;  Pedigree: W003507, EXP: 6/21/2014;  Pedigree: W003508, EXP: 6/21/2014;  Pedigree: W003764, EXP: 6/26/2014;  Pedigree: W003406, EXP: 6/19/2014.
Recall initiated: 20130702; classified: 20140116; reported: 20140122
Terminated: 20140207
FDA recall D-0333-2018 (Class II, Drugs) — status: Terminated
Recalling firm: Flawless Beauty LLC
Address: 1215 Main St , Asbury Park, NJ 07712-5940, United States
Recall type: Voluntary: Firm initiated; initial notification: Press Release
Product: Ling Zhi capsules
Reason for recall: Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act.
Distribution: Product was distributed U.S.A. nationwide.
Code info: all lots
Recall initiated: 20180119; classified: 20180205; reported: 20180214
Terminated: 20180913
FDA recall D-0508-2023 (Class II, Drugs) — status: Ongoing
Recalling firm: Direct Rx
Address: 94 Worldwide Dr , Dawsonville, GA 30534-6828, United States
Recall type: Voluntary: Firm initiated; initial notification: Letter
Product: Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b) 60 Tabs per bottle, NDC 72189-213-60; Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534.
Quantity: 349 bottles
Reason for recall: CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Distribution: Nationwide in the USA
Code info: Lots: a) 03FE2318, Exp. 8/31/24; b) 27FE2315, 28FE2313, 02MA2306, 21SE2201, 16NO2216, 17NO2216, 24FA2314, Exp. 8/31/24; 17FE2203, 12AP2204, 17MA2205, Exp. 3/31/23; 21JU2206, 22JU2220, 12JY2206, Exp. 5/31/23; 10AU2209, Exp. 6/30/23; 14DE2215, Exp. 9/30/24; 05JA2304, 27JA2301, Exp. 11/30/24.
Recall initiated: 20230322; classified: 20230406; reported: 20230412
FDA recall D-1253-2020 (Class II, Drugs) — status: Terminated
Recalling firm: Amneal Pharmaceuticals of New York, LLC
Address: 50 Horseblock Rd , Brookhaven, NY 11719-9509, United States
Recall type: Voluntary: Firm initiated; initial notification: Press Release
Product: Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
Quantity: 11258 bottles
Reason for recall: CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Distribution: Nationwide
Code info: 06598004A 04/2020  06599001A 12/2020  06599002A 12/2020
Recall initiated: 20200415; classified: 20200424; reported: 20200506
Terminated: 20210908
Drug details: brand_name: NIZATIDINE
generic_name: NIZATIDINE
manufacturer_name: Amneal Pharmaceuticals LLC
product_type: HUMAN PRESCRIPTION DRUG
route: ORAL
substance_name: NIZATIDINE
pharm_class_moa: Histamine H2 Receptor Antagonists [MoA]
pharm_class_epc: Histamine-2 Receptor Antagonist [EPC]
FDA recall D-844-2013 (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: Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203 702     Foreign packaging: b) Excedrin Migrana (Acetaminophen 250 mg, Aspirin 250 mg and 65 mg Caffeine) 2-ct pouches.  The foreign packaging do not have NDC numbers
Quantity: 10,624,000 pouches
Reason for recall: Defective container: products are packaged in pouches which may not have been fully sealed
Distribution: Nationwide, Puerto Rico, Brazil and Panama
Code info: Lot  # a) 10116809, Exp 5/13    Foreign: Lot #s b) 10115644 Exp 5/13; 10118226 Exp 5/13; 10118227 Exp 6/13; 10118228  Exp 6/13; 10121956 Exp 8/13 and 10121957 Exp 8/13
Recall initiated: 20130606; classified: 20130806; reported: 20130814
Terminated: 20141104
FDA recall D-707-2015 (Class II, Drugs) — status: Terminated
Recalling firm: Attix Pharmaceuticals
Address: 184 Front St E unit 801, Toronto,  N/A, Canada
Recall type: Voluntary: Firm initiated; initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product: Homatropine Methylbromide active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada
Quantity: 940 grams
Reason for recall: Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Distribution: Nationwide to compounding pharmacies and research organizations.
Code info: All lots repackaged and distributed between 01/05/12 to 02/12/15
Recall initiated: 20141114; classified: 20150420; reported: 20150429
Terminated: 20151007