FDA Drug Class II — Moderate

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

Hazard

Lack of Assurance of Sterility; due to leaking vials

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Products

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: Myl
Brand
Mylan Institutional LLC
UPC
Lot 7602368, Exp 7/16; Lot 7602369, Exp 7/16

Units Affected

2,523 cartons (25,936 vials)

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