FDA recall D-0693-2017

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

Distribution

Nationwide within the US and PR

Key facts

Status

Terminated

Initiation date

2016-12-12

Report date

2017-05-10

Termination date

2019-04-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Glasgow, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0693-2017