Recalls / Class II
Class IID-0342-2024
Product
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
- Brand name
- Adrenalin
- Generic names
- Epinephrine, Epineprine
- Active ingredient
- Epinephrine
- Route
- Intramuscular, Intravenous, Subcutaneous
- NDCs
- 42023-159, 42023-168, 0404-9810
- FDA application
- NDA204200
- Affected lot / code info
- Original Lot # 64103, exp. date 11/24 Repackaged Lot # 39747, exp. date 01/26
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Recalling firm
- Firm
- Henry Schein Inc. and Glove Club HSI Gloves Inc.
- Manufacturer
- Par Health USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 135 Duryea Rd, N/A, Melville, New York 11747-3834
Distribution
- Quantity
- 1,099 Single Dose Vials
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2024-01-17
- FDA classified
- 2024-02-21
- Posted by FDA
- 2024-02-28
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0342-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.