Drug & medication recalls Moderate risk

Apotex Inc. recalls Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane…

Recall date
September 24, 2019
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
D-0319-2020
FDA classification
Class II
Brand / firm
Apotex Inc.
Sold / distributed
Nationwide

Why it was recalled

GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8

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