Drug product
PGE-1, 20 mcg/mL Injection in Normal Saline, 10 mL, University Compounding Pharmacy, 855-398-1800.
D-1023-2013
Product summary
- Event
- Event 66206
- Status
- Terminated
- Classification
- Class II
- Quantity
- 85 mL
- Official record key
drug-enforcement:D-1023-2013
Official wording
Reason: Lack of Assurance of Sterility: University Compounding Pharmacy is voluntarily recalling certain pharmacy products due to lack of assurance of sterility concerns.
Code information: Lot #: 497940, Exp 9/6/2013
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility