October 2023 FDA Recall Drug by Imprimis Njof, Llc
D-0040-2024 - Subpotent
This Class III drug recall was voluntarily initiated by Imprimis Njof, Llc on October 3, 2023 for the product Drug. The FDA reported the reason for recall as subpotent. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0040-2024
Subpotent: Failing Test Results for Epinephrine
10-03-2023
10-11-2023
364 bags (1 mL filled in 2 mL glass amber vials; 20 vials shipped in a bag)
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
03-21-2025
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or (800)-FDA-1088 Imprimis NJOF, LLC. 1705 Route 46 West, Unit 6B, Ledgewood, NJ, 07852 (844) 446-6979
Batch or Lot Expiration Information
Lot# 23APR018
