The Recall Desk
HighFDA (Drugs)·D-1067-2022·Announced 2022-06-15

Levalbuterol tartrate HFA inhalation aerosol recalled for temperature abuse

Levalbuterol tartrate HFA inhalation aerosol is being recalled nationwide by McKesson Medical-Surgical due to temperature abuse during storage and distribution. The FDA has classified this as a Class II recall.

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 FDA Class II recall involves no reported illnesses or injuries, and the hazard—temperature-compromised drug quality—is theoretical. This meets the criteria for High severity as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Levalbuterol tartrate HFA inhalation aerosol, 45 mcg/actuation (NDC 0591-2927-54) manufactured by Teva Pharma USA and distributed by McKesson Medical-Surgical Inc., is being recalled nationwide. The product was distributed in packages of 2 inhalers.

The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations related to temperature abuse during storage and distribution. Temperature exposure can affect medication quality and efficacy. Because McKesson Medical-Surgical cannot identify specific lot numbers by customer, recall notifications to customers include distribution dates to help determine if product received falls within the affected timeframe.

The FDA has classified this as a Class II recall.

The recalled product

Product
LEVALBUTEROL TARTRATE HFA INHALATION (LEVALBUTEROL TARTRATE)
Brand
LEVALBUTEROL TARTRATE HFA INHALATION
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Respiratory / Inhalation
Hazard
  • temperature-abuse
  • potency-degradation

Distribution

Distributed nationwide across the United States.

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