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

Mckesson Medical-Surgical Inc. Corporate Office: Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61

Is my product affected?

Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61

  • Brand LEVOFLOXACIN

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

What happened

McKesson Medical-Surgical Inc. is recalling Levofloxacin Tablets, 500 mg in 100-count unit dose boxes manufactured by Major Pharma due to cGMP deviations caused by temperature abuse. The recall affects one box containing 100 blister packs that was distributed nationwide throughout the United States. Because McKesson is unable to identify the specific lot number received by individual customers, recall notifications include the distribution date to customers and the date range when affected product may have been shipped.

The source does not specify a remedy for this recall.

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 box/100 blisters packs per box 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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