Lorazepam Injection Recalled for Out-of-Specification Impurities and Degradation
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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical due to failed quality specifications for impurities and degradation. The product represents a risk-of-harm product where injury has not yet been reported, qualifying it as High severity per the rubric.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling approximately 82,700 vials of Lorazepam Injection, USP, 4mg/mL. The affected lot is Lot #070096, which expired in July 2023 and was distributed nationwide in the United States.
The U.S. Food and Drug Administration issued this Class II recall after testing revealed the product failed quality specifications for impurities and degradation. The lorazepam did not meet standards for total related compounds present in the medication.
Out-of-specification impurity and degradation levels in a pharmaceutical can affect product safety and effectiveness. The presence of these issues in tested samples triggered the recall of the entire lot.
Hikma Pharmaceuticals USA Inc. is the manufacturer and recalling firm. The affected product is identified by NDC codes 0641-6045-25 (carton) and 0641-6045-01 (individual vial).
The recalled product
- Product
- LORAZEPAM (LORAZEPAM)
- Brand
- LORAZEPAM
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Category
- Drug — Injectable Benzodiazepine
- Hazard
- impurities
- degradation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 070096
- exp. date 07/2023
Distribution
Distributed nationwide across the United States.
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