FDAFDA · Food and drugs·Recall number D-0422-2015
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
Published April 1, 2015 · Recall initiated: February 18, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility; due to leaking vials
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- HALOPERIDOL DECANOATE
- Manufacturer
- Mylan Institutional LLC
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot 7602368, Exp 7/16; Lot 7602369, Exp 7/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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