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.
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 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
- Affected units
- 2
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 →Related recalls
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