Why it was recalled
Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 070096, exp. date 07/2023
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1310-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 11, 2022
- FDA report date
- Aug 17, 2022
- Quantity
- 82,700 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
Original FDA data
Every field from FDA enforcement report D-1310-2022, exactly as published.
Show all FDA fields
- City
- Cherry Hill
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 90583
- Address
- 2 Esterbrook Ln
- Code information
- Lot # 070096, exp. date 07/2023
- Postal code
- 08003-4002
- Report date
- Aug 17, 2022
- Product type
- Drugs
- Recall number
- D-1310-2022
- Classification
- Class II
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Product quantity
- 82,700 vials
- Termination date
- Sep 14, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 11, 2022
- Initial firm notification
- Letter
- Center classification date
- Aug 5, 2022