Class II · Moderate risk
Lorazepam Injection
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Lorazepam Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Error on Declared Strength. Bottle labeled as 0.5 mg tablets contained 1mg tablets of lorazepam
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Lorazepam Tablets, USP CIV, 0.5 mg, 500-count bottle, Rx Only, Manufactured by: Leading Pharma, LLC Fairfield, NJ 07004 NDC 69315-904-05
Affected NDC
69315-0904-05
Compare with the code on your package — it is the most precise check available.
Drug: Lorazepam
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Lorazepam NDC 69315-0904 |
.5 mg/1 | Tablet Oral |
Leading Pharma, LLC | Rx · CIV |
- Recalling firm
- Leading Pharma, LLC
- NDC code
- 69315-904-05
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0085-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Lorazepam recalls
See all
Class II · Moderate risk
Lorazepam 0.5 mg per 0.25 mL Oral Syringe
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk
Lorazepam Tablets
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II · Moderate risk
Lorazepam Tablets
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Class II · Moderate risk
Lorazepam Tablets
Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Other recalls by Leading Pharma, LLC
All 2017 recalls
Class II · Moderate risk
Furosemide Tablets
CGMP Deviations; presence of N-nitroso-Furosemide (NNF) above the recommended intake limit.
Class III · Low risk
ClomiPRAMINE Hydrochloride Capsules
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
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