Drug & medication recalls Moderate risk

GSMS: Ranitidine Capsules 150 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 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70…
Recall number
D-0307-2020
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 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) 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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