Drug product
BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
D-0125-2023
Product summary
- Event
- Event 91443
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1200 vials
- Official record key
drug-enforcement:D-0125-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot#: 10252022@3, Exp 1/31/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility