Why it was recalled
Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: KP2621, Exp 8/2015
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D1834-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 21, 2015
- FDA report date
- Oct 7, 2015
- Quantity
- 2,075 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Inc.
Original FDA data
Every field from FDA enforcement report D1834-2015, exactly as published.
Show all FDA fields
- City
- Toronto
- State
- Ontario
- Status
- Terminated
- Country
- Canada
- Event ID
- 72118
- Address
- 150 Signet Drive
- Code information
- Lot #: KP2621, Exp 8/2015
- Report date
- Oct 7, 2015
- Product type
- Drugs
- Recall number
- D1834-2015
- Classification
- Class III
- Recalling firm
- Apotex Inc.
- Product quantity
- 2,075 bottles
- Termination date
- Feb 15, 2017
- Reason for recall
- Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jul 21, 2015
- Initial firm notification
- Letter
- Center classification date
- Sep 30, 2015