Recalls / Class II
Class IID-0536-2023
Product
Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-504-01; NDC Unit Dose: 60687-504-11, barcode (01) 003 60687 504 11 7.
- Affected lot / code info
- Lots: 1008622, 1010026, Exp 2/29/24
Why it was recalled
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Recalling firm
- Firm
- Amerisource Health Services LLC
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 695 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-03-16
- FDA classified
- 2023-04-14
- Posted by FDA
- 2023-04-26
- Terminated
- 2024-05-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0536-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.