Drug product
QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166.
D-0107-2023
Product summary
- Event
- Event 91443
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39 vials
- Official record key
drug-enforcement:D-0107-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot#: 11162022@10, Exp 12/31/2022; 12052022@9, Exp 1/19/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility