FDA recall D-0342-2024

Henry Schein Inc. and Glove Club HSI Gloves Inc. · Class II · drug

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

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.

Key facts

Status
Completed
Initiation date
2024-01-17
Report date
2024-02-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Melville, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0342-2024