Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05
Reported: October 16, 2019 Initiated: September 23, 2019 #D-0128-2020
Product Description
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05
Reason for Recall
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Details
- Recalling Firm
- Sandoz, Inc
- Units Affected
- 13,130 bottles
- Distribution
- U.S. Nationwide
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05. Recalled by Sandoz, Inc. Units affected: 13,130 bottles.
Why was this product recalled? ▼
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 16, 2019. Severity: Moderate. Recall number: D-0128-2020.
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