Lorazepam injection vials recalled for elevated impurities and degradation
Hikma Pharmaceuticals is recalling 1,352,475 vials of Lorazepam Injection due to failed quality tests showing elevated degradation compounds. Affected lots were distributed nationwide and in Puerto Rico.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II drug recall affecting a large quantity of injectable medication due to confirmed quality failure with elevated degradation products. Although no illnesses or injuries have been reported, degradation in a benzodiazepine injectable product presents a risk-of-harm to patients.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling Lorazepam Injection, USP, 2mg/mL vials (NDC 0641-6044-01 and -25) manufactured by West-Ward. A total of 1,352,475 vials are affected due to failed quality specifications.
During retained sample testing, out-of-specification results were found for total related compounds. Specifically, Related Compound-C was elevated beyond acceptable limits, indicating chemical degradation of the injectable product.
The affected lots (070086 and 070128, expiring July 2023) were distributed nationwide in the United States and Puerto Rico.
The recalled product
- Product
- LORAZEPAM (LORAZEPAM)
- Brand
- LORAZEPAM
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Category
- Drug — Benzodiazepine Injectable
- Affected units
- 1,352,475
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 (3)
- Lots: 070086
- 070128
- Exp. 07/2023
Distribution
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