NDC 63323-970
Benztropine Mesylate 1 mg per 1 mL injection, solution
On the label: Fresenius Kabi, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Melrose Park, IL, United States | Makes it | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
Recalls
- Jul 1, 2013 · Class II · Fresenius Kabi USA, LLC
Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
Lots: a) Lot: 111412, Exp: 11/2014 b) Lots: 030712, Exp: 03/2014; 071212, Exp: 07/2014; 090512, Exp: 09/2014;
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Benztropine: every company that makes it
- Form
- injection, solution, intramuscular; intravenous
- Strength
- 1 mg per 1 mL
- Approval
- ANDA ANDA090233
- On the market since
- May 31, 2011
- Package NDCs
63323-970-02- Official label
- DailyMed (National Library of Medicine), updated Oct 11, 2024
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