Status
Terminated
Drug Enforcement D-0436-2023
Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Classification
Class II
Report Date
March 15, 2023
Termination Date
May 12, 2024
Product Information
- Product description
- 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.
- Product quantity
- 422 cartons
- Reason for recall
- Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA
Location & Firm
- Recalling firm
- Amerisource Health Services LLC
- Address
-
2550 John Glenn Ave Ste A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0436-2023
- Event ID
- 91670
- Recall initiation date
- January 27, 2023
- Center classification date
- March 6, 2023
- Code info
- Lot 1009065, Exp 12/31/2023
- More code info
- —