Drug FDA Class II Ongoing Contamination / non-sterility
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
Imprimis NJOF, LLC Published Jun 5, 2024
Risk level
Class IIMay cause a temporary or reversible health problem; slight chance of serious harm.
Severity score 60/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Imprimis NJOF, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Lack of Assurance of Sterility
Hazards
Lack of Sterility Assurance · primary
Affected products (1)
Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraocular Injection, Rx only, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-509-08
18,980 vials
Code info: Lot #: 23OCT013, Exp. Date 10/10/2024
Affected areas
Nationwide
Timeline
- InitiatedMay 14, 2024
- PublishedJun 5, 2024
- Recall number
- D-0515-2024
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.