Drug 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
D-0421-2015
Product summary
- Event
- Event 70564
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,030 cartons (55,150 vials)
- Official record key
drug-enforcement:D-0421-2015
Official wording
Reason: Lack of Assurance of Sterility; due to leaking vials
Code information: Lot 7602281, Exp 4/16; Lot 7602283, Exp 4/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility