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Recall Observatory FDA recall evidence

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

D-0342-2024

January 17, 2024

Class II

Product summary

Firm
Henry Schein Inc. and Glove Club HSI Gloves Inc.
Event
Event 93839
Status
Completed
Classification
Class II
Quantity
1,099 Single Dose Vials
Official record key
drug-enforcement:D-0342-2024

Official wording

Reason: Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.

Code information: Original Lot # 64103, exp. date 11/24 Repackaged Lot # 39747, exp. date 01/26

Distribution pattern: USA nationwide.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing