Drug recall D-0615-2020
Product
Ranitidine Tablets, USP 150 mg, 1000-count bottles, NDC 53746-253-10.
Reason for recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Lots and codes
HB03718A 3/2020 HB03818A 3/2020 HB03918A 3/2020 HB04018A 3/2020 HC01618A 3/2020 HC14618A 5/2020 HC14718A 5/2020 HC14818A 5/2020 HC14918A 5/2020 HC15018A 5/2020 HK02318A 9/2020 HK02418A 9/2020 HK02518A 9/2020 HK02618A 9/2020 HD03119A 3/2021 HD03219A 3/2021 HE03119A 4/2021 HE03219A 4/2021
Recall details
- Recalling firm
- Amneal Pharmaceuticals, Inc., Brookhaven, NY
- Quantity
- N/A
- Distribution
- Product was distributed throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 22, 2019
Related products
- Ranitidine – drug information
- NDC 53746-254 Ranitidine · Ranitidine Hydrochloride 300 mg/1 · Amneal Pharmaceuticals of New York LLC
- NDC 53746-253 Ranitidine · Ranitidine Hydrochloride 150 mg/1 · Amneal Pharmaceuticals of New York LLC