Recalls / Class II
Class IID-0436-2023
Product
Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.
- Affected lot / code info
- Lot 1009065, Exp 12/31/2023
Why it was recalled
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Recalling firm
- Firm
- Amerisource Health Services LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 422 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-01-27
- FDA classified
- 2023-03-06
- Posted by FDA
- 2023-03-15
- Terminated
- 2024-05-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0436-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.