Drug 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
D-0693-2017
Product summary
- Event
- Event 76627
- Status
- Terminated
- Classification
- Class II
- Quantity
- 105,215 Bottles
- Official record key
drug-enforcement:D-0693-2017
Official wording
Reason: Failed Dissolution Specifications
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.
Distribution pattern: Nationwide within the US and PR
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications