D-0404-2021 Class II Terminated

Recalled by Cardinal Health Inc. — Dublin, OH

FDA drug recall D-0404-2021 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: 362 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
362 bottles

Product Description

Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories North Chicago, IL 60064, U.S.A.

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Distribution Pattern

FL, GA, SC

Code Information

1131141