NDC 64725-0471
Haloperidol Decanoate 100 mg per 1 mL injection
On the label: TYA Pharmaceuticals. It's repackaged: TYA Pharmaceuticals rebottles it from Fresenius Kabi, LLC's NDC 63323-471.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Melrose Park, IL, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
Repackaging site
- TYA Pharmaceuticals, Location not on file · repackages it and relabels it
Recalls
- Apr 7, 2016 · Class III · Fresenius Kabi USA, LLC
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
Lots: Lot #: 6111080, Exp. 01/2017 - Apr 14, 2014 · Class III · Fresenius Kabi USA LLC
Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.
Lots: Lot 6105149, Exp.05/14; 6105696, Exp. 07/14; 6105836, Exp. 08/14; Lot 6106516, Exp. 12/14; Lot 6106837, Exp. 02/15
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Haloperidol: every company that makes it
- Form
- injection
- Strength
- 100 mg per 1 mL
- Approval
- ANDA ANDA074893
- On the market since
- Jul 12, 2000
- Package NDCs
64725-0471-1- Official label
- DailyMed (National Library of Medicine), updated Jul 31, 2014
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