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

Mckesson Medical-Surgical Inc. Corporate Office: Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60

Is my product affected?

Ketoconazole Cream, 2%, Net Wt 60 grams tube, Rx only, MFG: Nycomed Inc, NDC 0168-0099-60

  • Brand KETOCONAZOLE

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

What happened

McKesson Medical-Surgical Inc. is recalling Ketoconazole Cream, 2% in 60-gram tubes manufactured by Nycomed Inc. The recall affects 6 tubes distributed nationwide across the United States due to temperature abuse during storage or handling, which represents a deviation from required manufacturing standards. McKesson is unable to identify the specific lot numbers that may have been received by individual customers, though each recall notification letter includes the distribution date and the timeframe during which affected product may have been shipped.

The source document does not specify a remedy or recommended action for consumers who may have received this product.

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: 6 tubes 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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