D-0342-2024 Class II
FDA drug recall D-0342-2024 was initiated by Henry Schein Inc. and Glove Club HSI Gloves Inc. on January 17, 2024 and is designated Class II. Reason for recall: Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect. Affected quantity: 1,099 Single Dose Vials.
Recall Details
- Product Type
- Drugs
- Report Date
- February 28, 2024
- Initiation Date
- January 17, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,099 Single Dose Vials
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
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Distribution Pattern
USA nationwide.
Code Information
Original Lot # 64103, exp. date 11/24 Repackaged Lot # 39747, exp. date 01/26