PlainRecalls
FDA Drug Moderate Class II Terminated

IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS)

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0437-2021

Product Description

IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS)

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
345 CARTONS
Distribution
FL, GA, SC
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS). Recalled by Cardinal Health Inc.. Units affected: 345 CARTONS.
Why was this product recalled?
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 2, 2021. Severity: Moderate. Recall number: D-0437-2021.