Drug recall D-0421-2015
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
Reason for recall
Lack of Assurance of Sterility; due to leaking vials
Lots and codes
Lot 7602281, Exp 4/16; Lot 7602283, Exp 4/16
Recall details
- Recalling firm
- Mylan Institutional LLC, Rockford, IL
- Quantity
- 11,030 cartons (55,150 vials)
- Distribution
- Nationwide and Puerto Rico
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 18, 2015
- Terminated
- February 23, 2017
Related products
- Haloperidol Decanoate – drug information
- NDC 67457-410 Haloperidol Decanoate · Haloperidol Decanoate 50 mg/mL · Mylan Institutional LLC
- NDC 67457-409 Haloperidol Decanoate · Haloperidol Decanoate 100 mg/mL · Mylan Institutional LLC