Lorazepam Injection Recalled for Out-of-Specification Impurities and Degradation
Hikma Pharmaceuticals is recalling Lorazepam Injection vials due to out-of-specification impurities and degradation products found during quality testing of retained samples.
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 out-of-specification impurities and degradation products. Quality failures in injectable medications represent a risk-of-harm situation where drug safety and efficacy could be compromised, even though no illnesses or injuries have been reported to date.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling Lorazepam Injection, USP, 2mg/mL, in 1 mL vials, due to out-of-specification results observed for total related compounds during testing of retained samples.
The recalled product includes lot number 070088 with expiration date July 2023, distributed nationwide in the United States. Approximately 713,550 vials are affected. The product is marketed under the brand name Lorazepam by Novaplus and is manufactured by Hikma in Berkeley Heights, New Jersey.
Lorazepam is a benzodiazepine medication administered by injection. Quality and purity are critical for injectable medications. Out-of-specification impurities or degradation products may affect drug safety and efficacy. Healthcare providers and patients with the affected product should consult their healthcare professional regarding this recall.
The recalled product
- Product
- LORAZEPAM (LORAZEPAM)
- Brand
- LORAZEPAM
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Category
- Drug
- Hazard
- impurities
- degradation-products
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 # 070088
- exp. date 07/2023
Distribution
Distributed nationwide across the United States.
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