PlainRecalls
FDA Drug Moderate Class II Terminated

LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS

Reported: June 2, 2021 Initiated: March 15, 2021 #D-0547-2021

Product Description

LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Details

Recalling Firm
Cardinal Health Inc.
Units Affected
2854 bottles
Distribution
FL, GA, SC
Location
Dublin, OH

Frequently Asked Questions

What product was recalled?
LORATADINE 10MG 100 ND 24H; NDC/UPC 345802650788; OTC; TABLETS. Recalled by Cardinal Health Inc.. Units affected: 2854 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-0547-2021.