Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-...
FDA Recall #D-0693-2017 — Class II — December 12, 2016
Product Description
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
Reason for Recall
Failed Dissolution Specifications
Recalling Firm
Amneal Pharmaceuticals LLC — Glasgow, KY
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
105,215 Bottles
Distribution
Nationwide within the US and PR
Code Information
Lot #: a) AR151324, AR151322, AR151325, Exp. 9/2017; AR160730A, AR160731A, AR160732A, Exp. 05/2018. b) AR151324, AR151322, AR151325, Exp. 9/2017; AR160730B, 5/2018.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated