Sandoz Ranitidine Hydrochloride Capsules 300mg 30 recall: Nitrosamine Impurity
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31
Why was Sandoz Ranitidine Hydrochloride Capsules 300mg 30 recalled?
CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
HD8625 4/30/2020 HD9275 4/30/2020 HU2207 8/31/2020 HX6676 3/31/2021 HX6677 3/31/2021
- Product
- Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31
- Recalling firm
- Sandoz, Inc
- Quantity
- 136,788 bottles
- Distribution
- U.S. Nationwide
- Recall date
- October 16, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)