Recalls / Class III
Class IIID1834-2015
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.
- Affected lot / code info
- Lot #: KP2621, Exp 8/2015
Why it was recalled
Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
Recalling firm
- Firm
- Apotex Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Signet Drive, N/A, Toronto, Ontario N/A, Canada
Distribution
- Quantity
- 2,075 bottles
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-07-21
- FDA classified
- 2015-09-30
- Posted by FDA
- 2015-10-07
- Terminated
- 2017-02-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D1834-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.