Recalls / Class II
Class IID-0421-2015
Product
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
- Brand name
- Haloperidol Decanoate
- Generic name
- Haloperidol Decanoate
- Active ingredient
- Haloperidol Decanoate
- Route
- Intramuscular
- NDCs
- 67457-409, 67457-410, 67457-382, 67457-381
- FDA application
- ANDA075440
- Affected lot / code info
- Lot 7602281, Exp 4/16; Lot 7602283, Exp 4/16
Why it was recalled
Lack of Assurance of Sterility; due to leaking vials
Recalling firm
- Firm
- Mylan Institutional LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4901 Hiawatha Dr, Rockford, Illinois 61103-1287
Distribution
- Quantity
- 11,030 cartons (55,150 vials)
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2015-02-18
- FDA classified
- 2015-03-23
- Posted by FDA
- 2015-04-01
- Terminated
- 2017-02-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0421-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.