D-0129-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- October 16, 2019
- Initiation Date
- September 23, 2019
- Termination Date
- July 14, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 136,788 bottles
Product Description
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31
Reason for Recall
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Distribution Pattern
U.S. Nationwide
Code Information
HD8625 4/30/2020 HD9275 4/30/2020 HU2207 8/31/2020 HX6676 3/31/2021 HX6677 3/31/2021