FDA Drug Recalls

Recalls / Class III

Class IIID-0651-2017

Product

Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by Cipla Limited Kurkumbh, Maharashtra, India, Manufactured for West-Ward, Pharmaceuticals, Corp., Eatontown, NJ -- NDC 0054-0338-19

Affected lot / code info
Lot KB60707, 10/31/2018

Why it was recalled

Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.

Recalling firm

Firm
West-Ward Columbus, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579

Distribution

Quantity
100 bottles
Distribution pattern
The recalled product was distributed to the following state: OH. There are no Canada accounts for this recall. There are no Mexico accounts for this recall. There are no government accounts for this recall.

Timeline

Recall initiated
2017-04-04
FDA classified
2017-04-07
Posted by FDA
2017-04-19
Terminated
2018-09-04
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-0651-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.