FDA (Drugs) recall action 90583
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Hikma Pharmaceuticals is recalling 82,700 vials of Lorazepam Injection due to failed quality specifications for impurities and degradation. Lot #070096 (expired July 2023) was distributed nationwide.
Hikma Pharmaceuticals is recalling Lorazepam Injection vials due to out-of-specification impurities and degradation products found during quality testing of retained samples.
Hikma Pharmaceuticals is recalling approximately 4.7 million vials of Lorazepam injection nationwide after finding out-of-specification related compounds during quality testing. The affected lots expire between June and August 2023.
Nationwide recall of Ativan (lorazepam) injection lot 060064Z due to out-of-specification impurities and degradation products. Patients should contact their healthcare provider.