← FDA ENFORCEMENT
D-0535-2025Class II
Imprimis NJOF, LLC
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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 & QualificationReason 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
2026-10-21Class IIZydus Pharmaceuticals (USA) Inc2026-10-21Class IIIMagellan Diagnostics, Inc.2026-10-21Class IIMicrogenics Corporation2026-10-14Class IICipla USA, Inc.
See all Validation & Qualification recalls →Data: U.S. FDA. 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. Open the enforcement explorer →