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Recall Observatory FDA recall evidence

Drug product

Levalbuterol Tartrate HFA Inhalation Aerosol, 45 mcg/actuation, 200 metered inhalations, Rx only, MFG: Teva Pharma USA, NDC 0591-2927-54

D-1067-2022

April 13, 2022

Class II

Product summary

Firm
Mckesson Medical-Surgical Inc. Corporate Office
Event
Event 89646
Status
Terminated
Classification
Class II
Quantity
2 inhalers
Official record key
drug-enforcement:D-1067-2022

Official wording

Reason: cGMP deviations: Temperature abuse

Code information: 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.

Distribution pattern: USA nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations