Nizatidine Capsules recall: Nitrosamine Impurity
Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Why was Nizatidine Capsules recalled?
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
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?
Lot # 3082876, exp. date January 2020 Lot # 3082877, exp. date January 2020
- Product
- Nizatidine Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Quantity
- 16,944 bottles of 30 capsules
- Distribution
- Product was distributed to wholesalers, distributors , retail pharmacies, charitable organizations and mail order pharmacies throughout the United States and the product may have been further distributed.
- Recall date
- January 29, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)