GSMS: Ranitidine Capsules 300 mg recalled over manufacturing violations
- Recall date
- November 6, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Golden State Medical Supply Inc. recalls GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70…
- Recall number
- D-0308-2020
- FDA classification
- Class II
- Brand / firm
- Golden State Medical Supply Inc.
- Sold / distributed
- AZ, IA, MA, MO
Why it was recalled
CGMP Deviations: Presence of NDMA impurity detected in product.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
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