Amneal Pharmaceuticals LLC recalls Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 65162
Recalled May 10, 2017 · FDA recall D-0693-2017 · Amneal Pharmaceuticals
Hazard
Failed Dissolution Specifications · FDA Class II
Units
105,215 Bottles
Sold at
Nationwide within the US and PR
Description
Failed Dissolution Specifications
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
Manufacturer(s)
Amneal Pharmaceuticals LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →