Epinephrine injection vials recalled for temperature abuse during distribution
Epinephrine injection vials are being recalled because they may have been exposed to improper temperatures during distribution, potentially affecting their 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 an FDA Class II recall of a risk-of-harm product (injectable epinephrine) due to temperature exposure that may compromise efficacy. No illnesses, injuries, or deaths have been reported. Per the severity rubric, risk-of-harm products where injury has not been reported score at 3 (High).
Plain-English summary
Pfizer epinephrine injection 0.1 mg/mL in 10 mL vials, supplied in 10-packs (NDC 04094-933-01), is being recalled because the product was exposed to improper storage temperatures during distribution. This temperature abuse constitutes a cGMP deviation that may affect product efficacy.
Approximately 172 packs containing 1,720 individual vials were distributed nationwide. Healthcare facilities and pharmacies who received affected shipments have been notified by McKesson Medical-Surgical with specific distribution dates and should immediately cease dispensing and use of product from those shipments and contact their supplier for further guidance.
The recalled product
- Product
- Epinephrine, ABJT 0.1 mg/mL, 10 mL, 20GX1.5 (10 pack), Rx only, MFG: Pfizer, NDC 04094-933-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug — Injectable Medication
- Hazard
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.
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