Moxifloxacin 1 mg/mL Solution Label Mix-up Recall
Denver Solutions, LLC (doing business as Leiters Health) is recalling Moxifloxacin 1 mg/mL intracameral injection solution because vials labeled as 1 mg/mL may actually contain 5 mg/mL, creating a serious dosing error risk.
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 FDA classified this as Class II. The hazard involves a five-fold concentration discrepancy in a prescription drug intended for direct intraocular injection, presenting significant risk of serious patient harm through overdosage. Although no specific illnesses or hospitalizations are mentioned in the source text, the inherent risk of a major dosing error in a potent antibiotic meets the Severe criterion for a Class II recall with serious potential for injury.
Plain-English summary
Denver Solutions, LLC, doing business as Leiters Health, is recalling Moxifloxacin 1 mg/mL intracameral injection solution due to a labeling mix-up. Vials labeled as containing 1 mg/mL of moxifloxacin may actually contain 5 mg/mL of the drug.
The recalled product is Moxifloxacin, 1 mg/mL, 1 mL in 2 mL vials, packaged 10 vials per carton, for prescription-only intracameral injection use. The specific lot affected is Lot #2130958 with an expiration date of March 31, 2022. Approximately 1,440 vials were distributed nationwide within the United States.
Patients who receive the wrong concentration may be exposed to a five-fold overdose of moxifloxacin. Healthcare providers and patients should immediately stop using vials from the recalled lot. Contact the manufacturer at (800) 292-6772 with questions or to report any adverse effects.
The recalled product
- Product
- Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, 10 vials/carton, Rx only, Leiters 13796 Compark Blvd, Englewood, CO 80112, (800) 292-6772, NDC 71449-096-42
- Manufacturer
- Denver Solutions, LLC DBA Leiters Health
- Affected units
- 1,440
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 #: 2130958
- Expiration Date 03/31/2022
Distribution
Distributed nationwide across the United States.
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