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, Br

FDA recall notice · announced May 10, 2017 · Amneal Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Notes

Distribution: Nationwide within the US and PR
Lot/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.
Quantity: 105,215 Bottles
Status: Terminated
Products in this recall event:
- 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 (D-0693-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.