Recalls / Class II
Class IID-0574-2023
Product
Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 25 x 1 mL Vials per carton (NDC 0641-6044-25), Rx only, Manufactured by West-Ward, Eatontown, NJ 07724.
- Brand name
- Lorazepam
- Generic name
- Lorazepam
- Active ingredient
- Lorazepam
- Route
- Intramuscular, Intravenous
- NDCs
- 0641-6044, 0641-6046, 0641-6045, 0641-6047
- FDA application
- NDA018140
- Affected lot / code info
- Lots: 070086, 070128, Exp. 07/2023
Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
Recalling firm
- Firm
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Esterbrook Ln, N/A, Cherry Hill, New Jersey 08003-4002
Distribution
- Quantity
- 1,352,475 vials
- Distribution pattern
- Nationwide in the USA and Puerto Rico
Timeline
- Recall initiated
- 2023-05-11
- FDA classified
- 2023-05-15
- Posted by FDA
- 2023-05-24
- Terminated
- 2023-12-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0574-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.