D-0557-2021 Class II Terminated

Recalled by Cardinal Health Inc. — Dublin, OH

FDA drug recall D-0557-2021 was initiated by Cardinal Health Inc. on March 15, 2021 and is designated Class II. Reason for recall: CGMP Deviations: Intermittent exposure to temperature excursion during storage. The recall status is terminated (terminated June 17, 2024). Affected quantity: 13 bottles.

Recall Details

Product Type
Drugs
Report Date
June 2, 2021
Initiation Date
March 15, 2021
Termination Date
June 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
13 bottles

Product Description

LEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Distribution Pattern

FL, GA, SC

Code Information

20D27