← FDA ENFORCEMENT
D-0512-2024Class II

Imprimis NJOF, LLC

Recalling firm
Imprimis NJOF, LLC
Product type
Drug
Status
Ongoing
Report date
2024-06-05
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
14,180 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Single-Use vials for Intraocular Injection, Imprimis NJOF, LLC. 1705 Route 46 West, unit 6B, Ledgewood, NJ 07852, NDC 71384-640-01

Code / lot info

Lot #: 23APR033, Exp. Date 5/1/24; 23JUN001, Exp. Date 6/5/24

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.