Adrenalin Injection
FDA Recall NDC 0404-9810
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Adrenalin (NDC 0404-9810). A significant event, classified as Class II, was initiated on Jan 17, 2024 by Henry Schein, Inc.. The reported reason for this action was: "Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Jan 17, 2024
Feb 28, 2024
1,099 Single Dose Vials
Recall Profile & Regulatory Data
Event ID
93839
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Henry Schein Inc. and Glove Club HSI Gloves Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Product Description
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
42023-159-01Product
42023-159-25Product
42023-168-01Product
0404-9810-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
