January 2024 FDA Recall Adrenalin by Henry Schein Inc. And Glove Club Hsi Gloves Inc.
D-0342-2024 - Labeling

This Class II drug recall was voluntarily initiated by Henry Schein Inc. And Glove Club Hsi Gloves Inc. on January 17, 2024 for the product Adrenalin. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently completed.

Recall Number: D-0342-2024

Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Initiated
01-17-2024
Reported
02-28-2024
Quantity
1,099 Single Dose Vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
93839
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Henry Schein Inc. and Glove Club HSI Gloves Inc.
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.
USA nationwide.
Product Description About Product Description
Full technical description of the product.
Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View Lane, Bastian, VA 24314, Original NDC 42023-159-25 Repack NDC 0404-9810-01

Batch or Lot Expiration Information

Lot# Original
Lot# 64103, exp. date 11/24 Repackaged
Lot# 39747, exp. date 01/26

Affected Packages Involved in this Recall

42023-159-01 Adrenalin
42023-159-25 Adrenalin
42023-168-01 Adrenalin
0404-9810-01 Adrenalin