Drug product
Verapamil Hydrochloride Extended-Release tablets, USP, 240 mg, 500-count bottles, Rx Only, Apotex Corp. Manufactured by Apotex Research Private Limited, Bangalore, Karnataka 560 099, India; Manufactured for: Apotex Corp., Weston, FL 33326. NDC 60505-2742-5.
D1834-2015
Product summary
- Firm
- Apotex Inc.
- Event
- Event 72118
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,075 bottles
- Official record key
drug-enforcement:D1834-2015
Official wording
Reason: Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
Code information: Lot #: KP2621, Exp 8/2015
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specification