Recalls / Class II
Class IID-0641-2020
Product
Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30
- Affected lot / code info
- 7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Recalling firm
- Firm
- Glenmark Pharmaceuticals Inc., USA
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 750 Corporate Dr, N/A, Mahwah, New Jersey 07430-2009
Distribution
- Quantity
- 98,988 bottles
- Distribution pattern
- Natiowide
Timeline
- Recall initiated
- 2019-12-17
- FDA classified
- 2020-01-05
- Posted by FDA
- 2020-01-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0641-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.