PlainRecalls
FDA Drug Moderate Class II Terminated

COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0569-2021

Product Description

COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

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

Frequently Asked Questions

What product was recalled?
COREG CR (carvedilol phosphate) Extended Release Capsules, 80 mg, 30-count bottle, Rx Only,/UPC 57664066683. Recalled by Cardinal Health Inc.. Units affected: 133 bottles.
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-0569-2021.