Amneal Pharmaceuticals LLC recalls Rabeprazole Sodium Delayed Release Tablets, 20 mg, a) 30-count bottle (NDC 65162-0724-03), b) 90-count bottle (NDC 6516…

Recall date

December 12, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0693-2017

FDA classification

Class II

Brand / firm

Amneal Pharmaceuticals LLC

Sold / distributed

Nationwide within the US and PR

Why it was recalled

Failed Dissolution Specifications

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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