Class II
Terminated
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31
- Company
- Sandoz Inc
- Recall Initiated
- September 23, 2019
- Posted
- October 16, 2019
- Recall Number
- D-0129-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 136,788 bottles
- Firm Location
- Princeton, NJ, United States
Reason for Recall
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Distribution
U.S. Nationwide
Lot / Code Info
HD8625 4/30/2020 HD9275 4/30/2020 HU2207 8/31/2020 HX6676 3/31/2021 HX6677 3/31/2021
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