FDA Drug Recalls

Recalls / Class II

Class IID-0515-2021

Product

VITAMIN D3 25MCG 90 TABLETS; NDC/UPC 880681168004; OTC; TABLETS

Affected lot / code info
All Lots distributed 02/23/2021 through 03/10/2021.

Why it was recalled

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Recalling firm

Firm
Cardinal Health Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091

Distribution

Quantity
53 BOTTLE
Distribution pattern
FL, GA, SC

Timeline

Recall initiated
2021-03-15
FDA classified
2021-05-24
Posted by FDA
2021-06-02
Terminated
2024-06-17
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0515-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls