The Recall Desk
HighFDA (Drugs)·D-1098-2022·Announced 2022-06-15

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.

What this means for you

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
  • temperature-abuse

Distribution

Distributed nationwide across the United States.

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