Drug Enforcement D-0478-2024

Out of specification for assay

Status

Ongoing

Classification

Class III

Report Date

May 8, 2024

Termination Date

—

Product Information

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
Product quantity
15,414 units
Reason for recall
Out of specification for assay
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

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

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

Codes & Dates

Recall number
D-0478-2024
Event ID
94372
Recall initiation date
April 10, 2024
Center classification date
April 30, 2024
Code info
Lot #: 23JUL028, Exp. Date 8/1/2024; 23AUG053, Exp. Date 8/30/2024
More code info
—