← FDA ENFORCEMENT
D-0535-2025Class II

Imprimis NJOF, LLC

Recalling firm
Imprimis NJOF, LLC
Product type
Drug
Status
Completed
Report date
2025-07-30
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
6,880 vials
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Sub-Potent Drug: Subpotent assay results during stability testing.

Product description

Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton, Rx Only, Imprimis NJOF, 1705 Route 46 West, Unit 6B Ledgewood, NJ, 07852 NDC: 71384-641-01

Code / lot info

Lot: 24DEC017, Exp. 07/12/2025.

Other recalls SPEQ maps to Validation & Qualification
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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.