May 2016 FDA Recall Oxycodone Hydrochloride by West-ward Columbus Inc
D-1441-2016 - Failed Impurities/Degradation Specification; 9 month stability
This Class III drug recall was voluntarily initiated by West-ward Columbus Inc on May 19, 2016 for the product Oxycodone Hydrochloride. The FDA reported the reason for recall as failed impurities/degradation specification; 9 month stability. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1441-2016
Failed Impurities/Degradation Specification; 9 month stability
05-19-2016
07-20-2016
1,182 bottles
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
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.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
02-02-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
Batch or Lot Expiration Information
Lot# 560185A; Exp. 6/30/2017
