Adrenalin (epinephrine) Injection 1mg/mL recall
FDA recall D-0342-2024 · initiated Jan 17, 2024
Henry Schein Inc. and Glove Club HSI Gloves Inc. recalled Adrenalin (epinephrine) Injection 1mg/mL in Jan 2024 — an FDA Class II recall (D-0342-2024) because Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,099 Single Dose Vials
Details
- 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
- Recalling company
- Henry Schein Inc. and Glove Club HSI Gloves Inc.
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- USA nationwide.
- Initiated
- Jan 17, 2024
- FDA report date
- Feb 28, 2024
This recall is linked to a product we cover: Adrenalin →
Frequently asked
- Was Adrenalin (epinephrine) Injection 1mg/mL recalled?
- Henry Schein Inc. and Glove Club HSI Gloves Inc. recalled Adrenalin (epinephrine) Injection 1mg/mL in Jan 2024 — an FDA Class II recall (D-0342-2024) because Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Adrenalin (epinephrine) Injection 1mg/mL recalled?
- Per the FDA enforcement record, the reason for recall D-0342-2024 was: Labeling: Incorrect or Missing Lot and/or Exp Date. The expiration date listed on the Repack Pouch Label is incorrect.
- Is a recalled Adrenalin (epinephrine) Injection 1mg/mL dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Adrenalin (epinephrine) Injection 1mg/mL are affected?
- Distributed: USA nationwide.. The recall covers these lots — Original Lot # 64103, exp. date 11/24 Repackaged Lot # 39747, exp. date 01/26. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0342-2024.