Class II · Moderate risk
Lorazepam Injection
Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Lorazepam
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
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, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60
Affected NDC
0904-6007-60
Compare with the code on your package — it is the most precise check available.
Drug: Lorazepam
- Recalling firm
- Legacy Pharmaceutical Packaging LLC
- NDC code
- 0904-6007-60
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-580-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 Legacy Pharmaceutical Packaging LLC
All 2013 recalls
Class II · Moderate risk
Sertraline Tablets
CGMP Deviations: Inadequate line clearance which may result in a potential comingling of product.
Class III · Low risk
Metformin Hydrochloride Tablets USP
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: Detection of trace amounts of N-Methylnitrosobutyric acid (NMBA) impurity found in the Active Pharmaceutical Ingredient (API)
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.
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