Class II · Moderate risk Ongoing
Lorazepam Injection
Reason Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Lorazepam Oral Concentrate
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Defective Delivery System: the dropper measurement markings may be reversed, shifted or missing.
What was recalled
Lorazepam Oral Concentrate, USP, 2 mg/mL, 30 mL bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Branchburg, NJ 08876. Distributed by: Amneal Pharmaceuticals, Glasgow, KY 42141. NDC 65162-687-84
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- NDC code
- 65162-687-84
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0120-2018
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Lorazepam recalls
See all
Class II · Moderate risk Ongoing
Lorazepam 0.5 mg per 0.25 mL Oral Syringe
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Class II · Moderate risk Ongoing
Lorazepam Tablets
Reason 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 Ongoing
Lorazepam Tablets
Reason 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 Ongoing
Lorazepam Tablets
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
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