The Recall Desk
SevereFDA (Drugs)·D-0177-2021·Announced 2021-01-06

Imprimis Recalls Dexamethasone-Moxifloxacin Injection Due to Sterility Concerns

Imprimis NJOF, LLC is recalling 6,520 vials of Dexamethasone-Moxifloxacin PF Injection because 13 vials were found with faulty crimps, raising concerns about sterility.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score (4) according to the rubric, particularly given the risk of infection from a lack of sterility assurance in an injectable drug.

Plain-English summary

Imprimis NJOF, LLC is recalling 6,520 vials of Dexamethasone-Moxifloxacin PF Injection (1/5) mg/mL. The recall is due to a lack of assurance of sterility, as 13 vials were discovered to have faulty crimps.

The affected product is identified by Lot # 20JUN010 and has an expiration date of 5/12/21. The recall covers distribution nationwide in the U.S.A.

Consumers and healthcare providers should stop using the affected product and contact Imprimis NJOF, LLC at (844) 446-6979 for further instructions.

The recalled product

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
Manufacturer
Imprimis NJOF, LLC
Affected units
6,520

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot#: 20JUN010
  • Exp 5/12/21

Distribution

Distributed nationwide across the United States.