Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
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 numbers, UPCs & expiration codes
Original Lot # 64103, exp. date 11/24 Repackaged Lot # 39747, exp. date 01/26
Where it was sold
USA nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0342-2024
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Jan 17, 2024
- FDA report date
- Feb 28, 2024
- Quantity
- 1,099 Single Dose Vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Henry Schein Inc. and Glove Club HSI Gloves Inc.
Original FDA data
Every field from FDA enforcement report D-0342-2024, exactly as published.
Show all FDA fields
- City
- Melville
- State
- NY
- Status
- Completed
- Country
- United States
- Event ID
- 93839
- Address
- 135 Duryea Rd
- Code information
- Original Lot # 64103, exp. date 11/24 Repackaged Lot # 39747, exp. date 01/26
- Postal code
- 11747-3834
- Report date
- Feb 28, 2024
- Product type
- Drugs
- Recall number
- D-0342-2024
- Classification
- Class II
- Recalling firm
- Henry Schein Inc. and Glove Club HSI Gloves Inc.
- Product quantity
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Jan 17, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 21, 2024