Drug recall D-0616-2020
Product
Ranitidine Tablets, USP 300 mg, 250-count bottles, NDC 53746-254-02.
Reason for recall
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Lots and codes
HB04118A 2/2020 HB04218A 2/2020 HB04318A 2/2020 HB04418A 2/2020 HF13518A 6/2020 HF13618A 6/2020 HF13718A 6/2020 HF13818A 6/2020 HK02818A 9/2020 HK02918A 9/2020 HK03018A 9/2020 HK03118A 9/2020 HL08418A 11/2020 HL08518A 11/2020 HL08618A 11/2020 HL08718A 11/2020 HB01419A 1/2021 HB05619A 1/2021 HB05719A 1/2021 HB05819A 1/2021 HB05919A 1/2021 HB06019A 1/2021 HB06119A 1/2021
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