FDA-Drug2015-04-01Class II
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
Mylan Institutional LLC
Hazard
Lack of Assurance of Sterility; due to leaking vials
Sold states
Nationwide and Puerto Rico
Affected count
11,030 cartons (55,150 vials)
Manufactured in
4901 Hiawatha Dr, Rockford, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0421-2015Don't want to check this manually?
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