Recalls / Class II
Class IID-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
- Affected lot / code info
- Lot #: a) AR151324, AR151322, AR151325, Exp. 9/2017; AR160730A, AR160731A, AR160732A, Exp. 05/2018. b) AR151324, AR151322, AR151325, Exp. 9/2017; AR160730B, 5/2018.
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Amneal Pharmaceuticals LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 118 Beaver Trl, Glasgow, Kentucky 42141-1273
Distribution
- Quantity
- 105,215 Bottles
- Distribution pattern
- Nationwide within the US and PR
Timeline
- Recall initiated
- 2016-12-12
- FDA classified
- 2017-05-02
- Posted by FDA
- 2017-05-10
- Terminated
- 2019-04-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0693-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.