Adrenalin Epinephrine Injection Recalled Due to Incorrect Expiration Date Label
Henry Schein Inc. and Glove Club HSI Gloves Inc. are recalling 1,099 vials of Adrenalin (Epinephrine) Injection because the expiration date on the repack pouch label is incorrect. The product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Incorrect expiration date on a risk-of-harm product (epinephrine is essential for anaphylaxis treatment). No injuries have been reported, but expired epinephrine could be ineffective in emergencies, creating significant patient risk.
Plain-English summary
Adrenalin (Epinephrine) Injection 1mg/mL in 1mL single-dose vials is being recalled by Henry Schein Inc. and Glove Club HSI Gloves Inc. due to an incorrect expiration date on the repack pouch label.
The affected repackaged lot (Lot # 39747, with expiration date 01/26) contains incorrect expiration date information on its pouch label. The recall involves 1,099 single-dose vials that were distributed nationwide.
Consumers and healthcare providers should not use this product. Contact your supplier or pharmacist for instructions on returning the affected vials. Healthcare providers should verify the actual expiration date with the manufacturer before administering any of this medication.
The recalled product
- Product
- ADRENALIN (EPINEPHRINE)
- Brand
- ADRENALIN
- Manufacturer
- Henry Schein Inc. and Glove Club HSI Gloves Inc.
- Category
- Drug
- Affected units
- 1,099
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Original Lot # 64103
- exp. date 11/24 Repackaged Lot # 39747
- exp. date 01/26
Distribution
Distributed nationwide across the United States.
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