Reported Apr 1, 2015 · Terminated
Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00)…
Mylan Institutional LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mylan Institutional LLC · 4901 Hiawatha Dr · Rockford, IL · 61103-1287
Is this the product you have?
- 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 forMylan Institutional LLC Rockford, IL 61103
- Lot codes and dates
Lot 7602281Exp 4/16Lot 7602283Exp 4/16
- Amount recalled
- 11,030 cartons (55,150 vials)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Lack of Assurance of Sterility; due to leaking vials
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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