Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 0591-2927-54
Check against the official notice below — it lists the full affected range.
McKesson Medical-Surgical Inc. is recalling Levalbuterol Tartrate HFA Inhalation Aerosol (45 mcg/actuation, 200 metered inhalations) manufactured by Teva Pharma USA due to current Good Manufacturing Practice (cGMP) deviations involving temperature abuse. The recall affects two inhalers distributed nationwide throughout the United States. McKesson is unable to identify the specific lot number received by individual customers, but has provided distribution dates and potential shipping dates for the affected product in recall letters to customers.
The source does not specify a remedy or course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
cGMP deviations: Temperature abuse
Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 2 inhalers Lot/code info: McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.