Drug product
Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1mL/vial, Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B Ledgewood, NJ - 07852 (844)446-6979
D-0177-2021
Product summary
- Event
- Event 87029
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6520 vials
- Official record key
drug-enforcement:D-0177-2021
Official wording
Reason: Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Code information: Lot#: 20JUN010, Exp 5/12/21
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility