Mckesson Medical-Surgical Inc. Corporate Office: Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61

Is my product affected?

Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61

• Brand IBUPROFEN

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

What happened

McKesson Medical-Surgical Inc. is recalling Ibuprofen Tablets USP, 400 mg, in 100-count unit dose boxes (prescription only, manufactured by Major Pharma, NDC 0904-5853-61) distributed nationwide in the USA. The recall was initiated due to cGMP deviations involving temperature abuse of the medication. One carton containing 100 blisters was affected, though McKesson is unable to identify the specific lot number that individual customers may have received.

The recall notice does not specify a remedy or instructions for what affected consumers should do with the recalled 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: 1 carton/100 blisters per carton 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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