Nizatidine Capsules recalled over manufacturing violations
- Recall date
- January 7, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Mylan Pharmaceuticals Inc. recalls Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
- Recall number
- D-0791-2020
- FDA classification
- Class II
- Brand / firm
- Mylan Pharmaceuticals Inc.
- Sold / distributed
- 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.
Why it was recalled
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Nizatidine Capsules, USP 150 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5150-91.
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