Drug product
AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0040-10
D-0919-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 528 vials
- Official record key
drug-enforcement:D-0919-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lot: K24409 BUD: 11/9/2022
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility