Drug 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
D-0422-2015
Product summary
- Event
- Event 70564
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,523 cartons (25,936 vials)
- Official record key
drug-enforcement:D-0422-2015
Official wording
Reason: Lack of Assurance of Sterility; due to leaking vials
Code information: Lot 7602368, Exp 7/16; Lot 7602369, Exp 7/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility