Drug Enforcement D-0535-2025

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

Status

Ongoing

Classification

Class II

Report Date

July 30, 2025

Termination Date

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Product Information

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
Product quantity
6,880 vials
Reason for recall
Sub-Potent Drug: Subpotent assay results during stability testing.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Imprimis NJOF, LLC
Address
1705 Route 46 Ste 6B, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0535-2025
Event ID
97183
Recall initiation date
July 9, 2025
Center classification date
July 21, 2025
Code info
Lot: 24DEC017, Exp. 07/12/2025.
More code info
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