The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1014-2022·Announced 2022-06-15

Epinephrine Auto-Injector Recalled for Temperature Abuse During Manufacturing and Distribution

Epinephrine auto-injectors distributed nationwide are being recalled due to temperature abuse during manufacturing. Temperature exposure may degrade the medication and reduce its emergency effectiveness.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class II FDA recall of a risk-of-harm product (epinephrine auto-injectors for emergency anaphylaxis treatment) with no reported illnesses or injuries. Per the severity rubric, recalls involving risk-of-harm products where injury has not yet been reported score 3 (High).

Plain-English summary

McKesson Medical-Surgical is recalling approximately 30 packs of Epinephrine Injection, USP, Single-Dose Auto-Injectors (0.15 mg, 2-count cartons) that were distributed nationwide. The recall was initiated due to cGMP deviations: temperature abuse during manufacturing and distribution of the product.

Epinephrine is a prescription emergency medication used to treat severe allergic reactions and anaphylaxis. Temperature exposure during manufacturing and distribution may cause the medication to degrade. McKesson was unable to identify specific lot numbers for individual consignees and instead notified customers with the dates affected product may have been shipped to them.

Patients and healthcare providers who have this recalled product should contact McKesson Medical-Surgical or their healthcare provider about replacement options and appropriate next steps.

The recalled product

Product
EPINEPHRINE (EPINEPHRINE)
Brand
EPINEPHRINE
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug
Hazard
Affected units
30

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 130 products in this recall →

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