PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1055-2022

Product Description

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

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
1 carton/100 blisters per carton
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 1 carton/100 blisters per carton.
Why was this product recalled?
cGMP deviations: Temperature abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-1055-2022.