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FDA (Drug enforcement)Recalled 2022-04-13closedclass ii

Mckesson Medical-Surgical Inc. Corporate Office: Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalations, Rx only, Distributed by: Sandoz Inc., NDC 0781-7296-85

Is my product affected?

Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalations, Rx only, Distributed by: Sandoz Inc., NDC 0781-7296-85

  • Brand ALBUTEROL SULFATE

Check against the official notice below — it lists the full affected range.

What happened

McKesson Medical-Surgical Inc. is recalling Albuterol Sulfate Inhalation Aerosol HFA 90 mcg (200 metered inhalations) distributed by Sandoz Inc. nationwide in the United States. The recall was initiated due to Good Manufacturing Practice (cGMP) deviations involving temperature abuse of the product during distribution.

The company has not been able to identify the specific lot numbers for individual customers who received the affected inhalation aerosol. Customers who received this product were notified by letter containing the distribution date and the dates when potentially impacted product may have been shipped to them. The source does not specify a remedy or required consumer action.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

cGMP deviations: Temperature abuse

Details from the source

Reason for recall: cGMP deviations: Temperature abuse Distribution: USA nationwide. Quantity: 1 aerosol 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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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