D-0421-2015 Class II Terminated
FDA drug recall D-0421-2015 was initiated by Mylan Institutional LLC on Feb 18, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; due to leaking vials The recall status is terminated (terminated Feb 23, 2017). Affected quantity: 11,030 cartons (55,150 vials).
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 1, 2015
- Initiation Date
- Feb 18, 2015
- Termination Date
- Feb 23, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,030 cartons (55,150 vials)
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
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot 7602281, Exp 4/16; Lot 7602283, Exp 4/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0421-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026