Recalls / Class II
Class IID-1309-2022
Product
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# 0641-6048-25, Vial NDC# 0641-6048-01
- Brand name
- Lorazepam
- Generic name
- Lorazepam
- Active ingredient
- Lorazepam
- Route
- Intramuscular, Intravenous
- NDCs
- 0641-6048, 0641-6050, 0641-6049, 0641-6051
- FDA application
- NDA018140
- Affected lot / code info
- Lot # 070088, exp. date 07/2023
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Recalling firm
- Firm
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Esterbrook Ln, Cherry Hill, New Jersey 08003-4002
Distribution
- Quantity
- 713,550 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-07-11
- FDA classified
- 2022-08-05
- Posted by FDA
- 2022-08-17
- Terminated
- 2023-09-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1309-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.