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

FDA recall notice · announced January 6, 2021 · Imprimis Njof

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.

Notes

Distribution: U.S.A. Nationwide
Lot/code information: Lot#: 20JUN010, Exp 5/12/21
Quantity: 6520 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.