Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009
Lorazepam, 0.5 mg tablets, 100 count, RX only, Distributed by Major Pharmaceuticals, Livonia, MI. NDC 0904-6007-60
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.
Reason Failed Impurities/Degradation Specifications: An out-of-Specification for total related compounds
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…
Reason Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.