NDC 68071-3227
Lorazepam 1 mg tablet
On the label: NuCare Pharmaceuticals.Inc.. It's repackaged: NuCare Pharmaceuticals.Inc. rebottles it from Leading Pharma, LLC's NDC 69315-905.
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
- NuCare Pharmaceuticals,Inc., Orange, CA, United States · 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: N01419, N01420, N01421, Exp 03/31/2025; N01663, Exp 06/30/2025; N01664, Exp 08/31/2025; N01673, Exp 09/30/2025; N01688, Exp 08/31/2025; N01747, N01748, N01749, Exp 11/30/2025; N01792, Exp 12/31/2025; N01857, Exp 02/28/2026; N01974, Exp 05/31/2026; N02081, 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, oral
- Strength
- 1 mg
- Approval
- ANDA ANDA078203
- On the market since
- Oct 1, 2007
- Package NDCs
68071-3227-168071-3227-268071-3227-368071-3227-568071-3227-668071-3227-768071-3227-9- Official label
- DailyMed (National Library of Medicine), updated Nov 13, 2024
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