Drug recall D-0194-2024

Class II Terminated reported Jan 3, 2024

Product

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

Reason for recall

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

Lots and codes

Batch 100023596

Recall details

Recalling firm
CARDINAL HEALTHCARE, Dublin, OH
Quantity
2 units
Distribution
Nationwide USA
Type
Voluntary: Firm initiated
Recall initiated
January 26, 2022
Terminated
September 29, 2024

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