FDA recall D-0177-2021

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.

Distribution

U.S.A. Nationwide

Key facts

Status

Terminated

Initiation date

2020-12-17

Report date

2021-01-06

Termination date

2023-08-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ledgewood, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0177-2021