Class II
Terminated
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
This recall has been terminated (originally issued April 1, 2015).
- Company
- Mylan Institutional Llc
- Recall Initiated
- February 18, 2015
- Posted
- April 1, 2015
- Recall Number
- D-0422-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,523 cartons (25,936 vials)
- Firm Location
- Rockford, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility; due to leaking vials
Distribution
Nationwide and Puerto Rico
Lot / Code Info
Lot 7602368, Exp 7/16; Lot 7602369, Exp 7/16
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