Drug product
Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110
D-1068-2015
Product summary
- Event
- Event 70807
- Status
- Terminated
- Classification
- Class II
- Quantity
- 43 vials
- Official record key
drug-enforcement:D-1068-2015
Official wording
Reason: Lack of assurance of sterility
Code information: Lot#: a) 10272014@1, Exp 4/27/15; b) 11042014@60, Exp 4/12/15; c) 11192014@43, Exp 4/12/15; d) 12042014@32, Exp 4/12/15; e) 12182014@46; Exp 4/12/15; f) 12232014@8, 12242014@16, Exp 4/12/15; g) 12312014@40, Exp 4/12/15
Distribution pattern: New York
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility