PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 6, 2021 Initiated: December 17, 2020 #D-0177-2021

Product Description

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.

Details

Recalling Firm
Imprimis NJOF, LLC
Units Affected
6520 vials
Distribution
U.S.A. Nationwide
Location
Ledgewood, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Imprimis NJOF, LLC. Units affected: 6520 vials.
Why was this product recalled?
Lack of assurance of sterility: 13 vials were discovered to have faulty crimps.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 6, 2021. Severity: Moderate. Recall number: D-0177-2021.