Recalls / Class II
Class IID-0648-2020
Product
Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
- Affected lot / code info
- Batch # 1905227UE, exp. date Apr-2021 1905228UE, exp. date Apr-2021
Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Recalling firm
- Firm
- Appco Pharma LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 262 Old New Brunswick Rd Unit N, N/A, Piscataway, New Jersey 08854-3756
Distribution
- Quantity
- 1,632 bottes
- Distribution pattern
- Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
Timeline
- Recall initiated
- 2020-01-07
- FDA classified
- 2020-01-07
- Posted by FDA
- 2020-01-15
- Terminated
- 2020-04-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0648-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.