Ranitidine 150 mg tablets recalled over manufacturing violations
- Recall date
- December 26, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- AAA Pharmaceutical, Inc. recalls Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
- Recall number
- D-0645-2020
- FDA classification
- Class II
- Brand / firm
- AAA Pharmaceutical, Inc.
- Sold / distributed
- Product was distributed to one consignee who may have distributed the product further to their retail stores.
Why it was recalled
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Ranitidine 150 mg tablets, 24 count bottles, NDC 37808-196-01.
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