April 2017 FDA Recall Drug by West-ward Columbus, Inc.
D-0651-2017 - Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.

This Class III drug recall was voluntarily initiated by West-ward Columbus, Inc. on April 4, 2017 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications; during an internal inspection, capsules were found with illegible print.. The product was distributed in 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. and the recall is currently terminated.

Recall Number: D-0651-2017

Reason for Recall
Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with illegible print.
Initiated
04-04-2017
Reported
04-19-2017
Quantity
100 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
76822
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
West-Ward Columbus, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial 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.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
09-04-2018
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot KB60707, 10/31/2018