April 2024 FDA Recall Drug by Imprimis Njof, Llc
D-0478-2024 - Out of specification for assay

This Class III drug recall was voluntarily initiated by Imprimis Njof, Llc on April 10, 2024 for the product Drug. The FDA reported the reason for recall as out of specification for assay. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0478-2024

Reason for Recall
Out of specification for assay
Initiated
04-10-2024
Reported
05-08-2024
Quantity
15,414 units

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94372
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Imprimis NJOF, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
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

Batch or Lot Expiration Information

Lot# : 23JUL028, Exp. Date 8/1/2024; 23AUG053, Exp. Date 8/30/2024