FDA recall record

Adrenalin (epinephrine) Injection 1mg/mL, 1mL single dose vial recall — FDA D-0342-2024

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

Class IIclassification
D-0342-2024official record ID
Feb 28, 2024report date

Recall record at a glance

Official recordD-0342-2024
CategoryDrug Recalls
ClassificationClass II
FDA record statusCompleted
Recalling firmHenry Schein Inc. and Glove Club HSI Gloves Inc.
Report dateFeb 28, 2024
Recall initiation dateJan 17, 2024
Quantity1,099 Single Dose Vials
LocationMelville, NY, United States

Official 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

Why the product was recalled

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

Distribution information

USA nationwide.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.

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