NDC 67046-924
Lorazepam 0.5 mg tablet
On the label: Coupler Enterprises Inc.. It's repackaged: Coupler Enterprises Inc. rebottles it from Leading Pharma, LLC's NDC 69315-904.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Leading Pharma, LLC | Fairfield, NJ, United States | Makes it | Problems found, fixed voluntarilyOct 21, 2024 · 13 inspections |
Repackaging site
- Coupler Enterprises, Location not on file · repackages it
Recalls
- Jan 21, 2025 · Class II · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lots: Lot #s: N01424, N01425, Exp 03/31/2025; N01659, N01660, Exp 08/31/2025; N01668, 09/2025; N01679, N01704, N01745, Exp 10/31/2025; N01856, Exp 02/28/2026; N01973, Exp 05/31/2026; N02079, Exp 08/31/2026. - Sep 28, 2017 · Class II · Leading Pharma, LLC
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Lots: Lot #E00717
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Lorazepam: every company that makes it
- Form
- tablet
- Strength
- 0.5 mg
- Approval
- ANDA ANDA078203
- On the market since
- Oct 1, 2007
- Package NDCs
67046-924-30- Official label
- DailyMed (National Library of Medicine), updated Sep 14, 2017
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