D-0450-2021 Class II Terminated

Recalled by Cardinal Health Inc. — Dublin, OH

FDA drug recall D-0450-2021 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: 67 BOXES.

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
67 BOXES

Product Description

SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS

Reason for Recall

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Distribution Pattern

FL, GA, SC

Code Information

2003060A