Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60

FDA recall notice · announced October 16, 2019 · Sandoz

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60

Reason for recall

CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).

Notes

Distribution: U.S. Nationwide
Lot/code information: HC9266 4/30/2020 HD1865 4/30/2020 HP9441 9/30/2020 JK7994 8/31/2021 JK8659 8/31/2021
Quantity: 100,314 bottles
Status: Terminated
Products in this recall event:
- Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05 (D-0128-2020)
- Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31 (D-0129-2020)
- Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60 (D-0127-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.