FDA Drug Recalls

Recalls / Class II

Class IID-0902-2017

Product

Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392.

Affected lot / code info
Lot # A18705, Exp. 09/30/2017

Why it was recalled

CGMP Deviations

Recalling firm

Firm
Safecor Health, LLC
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
317 New Boston St, N/A, Woburn, Massachusetts 01801-6231

Distribution

Quantity
25 bottles
Distribution pattern
MA and NY

Timeline

Recall initiated
2016-07-07
FDA classified
2017-06-12
Posted by FDA
2017-06-21
Terminated
2017-07-12
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0902-2017. 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