Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Packaged By: Henry Schein, Inc., 80 Summit View
Summary
The FDA issued a Class II for Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial, Rx only, Package by Henry Schein Inc. and Glove Club HSI Gloves Inc.. Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect..
Details
Source
Drug Recall
External ID
D-0342-2024
Action Date
2024-02-28
Status
Completed
Category
drug
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
Lot/Code Info: Original Lot # 64103, exp. date 11/24 Repackaged Lot # 39747, exp. date 01/26
Quantity Affected: 1,099 Single Dose Vials
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-17
Company
Melville, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 41 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Henry Schein Inc. and Glove Club HSI Gloves Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Henry Schein Inc. and Glove Club HSI Gloves Inc. have FDA actions?
This is the only FDA action we have on record for Henry Schein Inc. and Glove Club HSI Gloves Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0342-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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