Multi-event February 2015 FDA Recall Haloperidol Decanoate by Mylan Institutional Llc
This Multi-event Class II drug recall was voluntarily initiated by Mylan Institutional Llc on February 18, 2015 for the product Haloperidol Decanoate. The FDA reported the reason for recall as lack of assurance of sterility; due to leaking vials. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0421-2015
Lack of Assurance of Sterility; due to leaking vials
02-18-2015
04-01-2015
11,030 cartons (55,150 vials)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Mylan Institutional 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
02-23-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of five (NDC 67457-409-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
Batch or Lot Expiration Information
Lot# Lot 7602281, Exp 4/16; Lot 7602283, Exp 4/16
Affected Packages Involved in this Recall
Recall Number: D-0422-2015
Lack of Assurance of Sterility; due to leaking vials
02-18-2015
04-01-2015
2,523 cartons (25,936 vials)
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
Mylan Institutional 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
02-23-2017
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Haloperidol Decanoate Injection, 50 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-410-00) packaged in cartons of ten (NDC 67457-410-13), Rx only, Manufactured in India for: Mylan Institutional LLC Rockford, IL 61103
Batch or Lot Expiration Information
Lot# Lot 7602368, Exp 7/16; Lot 7602369, Exp 7/16
