Drug product
Papaverine/phentolamine/prostaglandin 30/4/0.04 mg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
D-1069-2015
Product summary
- Event
- Event 70807
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 vials
- Official record key
drug-enforcement:D-1069-2015
Official wording
Reason: Lack of assurance of sterility
Code information: Lot #: a) 1031-2014@51; Exp 3/18/15; b) 12152014@24; Exp 4/12/15
Distribution pattern: New York
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility