FDA Drug recall D-0421-2015
Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of f…
- FDA Drug
- Class II
- terminated
- Published 2015-04-01
On 2015-04-01 the FDA classified a Class II recall of Haloperidol Decanoate Injection, 100 mg/mL, For Intra Muscular Use Only, 1 mL single dose vials (NDC 67457-409-00) packaged in cartons of f… by Mylan Institutional, citing lack of Assurance of Sterility; due to leaking vials.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0421-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-02-18 |
| Published | 2015-04-01 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Institutional |
| Distribution | US |
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
Reason
Lack of Assurance of Sterility; due to leaking vials
Identifiers
| ndc | 67457-410-00 |
|---|---|
| ndc | 67457-410-13 |
| ndc | 67457-409-00 |
| ndc | 67457-409-13 |
| code_info | Lot 7602281, Exp 4/16; Lot 7602283, Exp 4/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0421-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.