Drug product
Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377
D-1510-2016
Product summary
- Event
- Event 74606
- Status
- Terminated
- Classification
- Class II
- Quantity
- 450 mL
- Official record key
drug-enforcement:D-1510-2016
Official wording
Reason: Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.
Code information: LOT #: 06201604@15, 19201602@3, 06201604@8
Distribution pattern: MN
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility