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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Category
- Drug — Injectable
- 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.
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