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
Reported: April 1, 2015 Initiated: February 18, 2015 #D-0421-2015
Product Description
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
Reason for Recall
Lack of Assurance of Sterility; due to leaking vials
Details
- Recalling Firm
- Mylan Institutional LLC
- Units Affected
- 11,030 cartons (55,150 vials)
- Distribution
- Nationwide and Puerto Rico
- Location
- Rockford, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Mylan Institutional LLC. Units affected: 11,030 cartons (55,150 vials).
Why was this product recalled? ▼
Lack of Assurance of Sterility; due to leaking vials
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 1, 2015. Severity: Moderate. Recall number: D-0421-2015.
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