D1834-2015 Class III Terminated
FDA drug recall D1834-2015 was initiated by Apotex Inc. on Jul 21, 2015 and is designated Class III. Reason for recall: Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits. The recall status is terminated (terminated Feb 15, 2017). Affected quantity: 2,075 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Oct 7, 2015
- Initiation Date
- Jul 21, 2015
- Termination Date
- Feb 15, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,075 bottles
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.
Reason for recall
Failed Dissolution Specification: One lot of product did not meet the first stage dissolution specification limits.
Distribution pattern
Nationwide and Puerto Rico
Code information
Lot #: KP2621, Exp 8/2015
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D1834-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026