Recalling firm
Imprimis NJOF, LLC
Product type
Drug
Status
Ongoing
Report date
2024-05-08
Distribution
Nationwide within the United States
Firm state
NJ
Product quantity
15,414 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
Out of specification for assay
Product description
Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL Single-Use vials, Rx only, Imprimis NJOF, LLC 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852, NDC 71384-640-01
Code / lot info
Lot #: 23JUL028, Exp. Date 8/1/2024; 23AUG053, Exp. Date 8/30/2024
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →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.