April 2016 FDA Recall Haloperidol Decanoate by Fresenius Kabi Usa, Llc
D-0818-2016 - Failed Impurities/Degradation Specifications
This Class III drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on April 7, 2016 for the product Haloperidol Decanoate. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0818-2016
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
04-07-2016
04-20-2016
48,210 units
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.
Fresenius Kabi USA, LLC
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 and Puerto Rico
11-07-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
Batch or Lot Expiration Information
Lot# : 6111080, Exp. 01/2017
