Recalls / Class II
Class IID-0613-2020
Product
Ranitidine Tablets, USP 300 mg - a).30-count bottles (NDC 65162-254-30), b).100-count bottles (NDC 65162-254-10) and c). 250-count bottles (NDC 65162-254-25).
- Affected lot / code info
- AR172033B 11/2019 AR180024A 12/2019 AR180025A 12/2019 AR180118A 12/2019 AR180119A 12/2019 AR180519A 3/2020 AR180615A 3/2020 AR181795A 11/2020 AR181921B 12/2020 AR190705A 4/2021 AR172029A 11/2019 AR172030A 11/2019 AR180021A 12/2019 AR180022A 12/2019 AR180023A 12/2019 AR180123A 12/2019 AR180144A 1/2020 AR180145A 1/2020 AR180146A 1/2020 AR180147A 1/2020 AR180402A 2/2020 AR180465A 2/2020 AR180466A 2/2020 AR180467A 2/2020 AR180468A 2/2020 AR180613A 3/2020 AR181156A 7/2020 AR181157A 7/2020 AR190418B 2/2021 AR171800A 11/2019 AR171801A 11/2019 AR171802A 11/2019 AR171803A 11/2019 AR171804A 11/2019 AR171931A 11/2019 AR171932A 11/2019 AR171933A 11/2019 AR171934A 11/2019 AR171935A 11/2019 AR171936A 11/2019 AR171937A 11/2019 AR172026A 11/2019 AR172027A 11/2019 AR172028A 11/2019 AR172031A 11/2019 AR172032A 11/2019 AR172033A 11/2019 AR172034A 11/2019 AR172035A 11/2019 AR180030A 12/2019 AR180031A 12/2019 AR180032A 12/2019 AR180033A 12/2019 AR180034A 12/2019 AR180113A 12/2019 AR180114A 12/2019 AR180115A 12/2019 AR180117A 12/2019 AR180120A 12/2019 AR180121A 12/2019 AR180122A 12/2019 AR180148A 1/2020 AR180198A 1/2020 AR180199A 1/2020 AR180200A 1/2020 AR180201A 1/2020 AR180202A 1/2020 AR180257A 1/2020 AR180258A 1/2020 AR180335A 2/2020 AR180336A 2/2020 AR180337A 2/2020 AR180338A 2/2020 AR180339A 2/2020 AR180374A 2/2020 AR180375A 2/2020 AR180376B 2/2020 AR180403A 2/2020 AR180404A 2/2020 AR180405A 2/2020 AR180406A 2/2020 AR180424A 2/2020 AR180486A 3/2020 AR180487A 3/2020 AR180488A 3/2020 AR180515A 3/2020 AR180516A 3/2020 AR180517A 3/2020 AR180518A 3/2020 AR180638A 3/2020 AR180640A 4/2020 AR180641A 4/2020 AR181920A 12/2020 AR181921A 12/2020 AR190414B 2/2021 AR190415A 2/2021 AR190416A 2/2021 AR190417A 2/2021 AR190418A 2/2021 AR190543A 3/2021 AR190544A 3/2021 AR190545A 3/2021
Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm
- Firm
- Amneal Pharmaceuticals, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 50 Horseblock Rd, N/A, Brookhaven, New York 11719-9509
Distribution
- Quantity
- N/A
- Distribution pattern
- Product was distributed throughout the United States.
Timeline
- Recall initiated
- 2019-11-22
- FDA classified
- 2019-12-09
- Posted by FDA
- 2019-12-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0613-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.