FDAFDA · Food and drugs·Recall number D-1310-2022
Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, Novaplus, Manufactured by Hikma Berkeley Heights, NJ 07922. Carton NDC# NDC# 0641-6045-25, Vial NDC# 0641-6045-01
Published August 17, 2022 · Recall initiated: July 11, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- LORAZEPAM
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Distributor
- Nationwide in the USA
- Lot
- Lot # 070096, exp. date 07/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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