FDA recall D-0651-2017

West-Ward Columbus, Inc. · Class III · drug

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

Reason for recall

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

Distribution

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.

Key facts

Status
Terminated
Initiation date
2017-04-04
Report date
2017-04-19
Termination date
2018-09-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0651-2017