Recalls / Class II
Class IID-0127-2020
Product
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
- Affected lot / code info
- HC9266 4/30/2020 HD1865 4/30/2020 HP9441 9/30/2020 JK7994 8/31/2021 JK8659 8/31/2021
Why it was recalled
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Recalling firm
- Firm
- Sandoz, Inc
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 506 Carnegie Ctr Ste 400, N/A, Princeton, New Jersey 08540-6243
Distribution
- Quantity
- 100,314 bottles
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2019-09-23
- FDA classified
- 2019-10-07
- Posted by FDA
- 2019-10-16
- Terminated
- 2023-07-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0127-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.