RecallDepth
Class II Terminated

Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162-0724-09), Rx Only, Manufactured by Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad INDIA 382220, Distributed by Amneal Pharmaceuticals, Bridgewater, NJ 08807

Company
Amneal Pharmaceuticals Llc
Recall Initiated
December 12, 2016
Posted
May 10, 2017
Recall Number
D-0693-2017
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
105,215 Bottles
Firm Location
Glasgow, KY, United States

Reason for Recall

Failed Dissolution Specifications

Distribution

Nationwide within the US and PR

Lot / Code Info

Lot #: a) AR151324, AR151322, AR151325, Exp. 9/2017; AR160730A, AR160731A, AR160732A, Exp. 05/2018. b) AR151324, AR151322, AR151325, Exp. 9/2017; AR160730B, 5/2018.

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