FDAJanuary 26, 2022drug

Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

What to do

FDA enforcement status: Terminated

Brands named

cardinal healthcarecardinal

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1 — Recall Details · AllClear