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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lots: 070086, 070128, Exp. 07/2023
Where it was sold
Nationwide in the USA and Puerto Rico
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-0574-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 11, 2023
- FDA report date
- May 24, 2023
- Quantity
- 1,352,475 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
Original FDA data
Every field from FDA enforcement report D-0574-2023, exactly as published.
Show all FDA fields
- City
- Cherry Hill
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 92320
- Address
- 2 Esterbrook Ln
- Code information
- Lots: 070086, 070128, Exp. 07/2023
- Postal code
- 08003-4002
- Report date
- May 24, 2023
- Product type
- Drugs
- Recall number
- D-0574-2023
- Classification
- Class II
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Product quantity
- 1,352,475 vials
- Termination date
- Dec 12, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications: Out-of-specification results for total related compounds observed during retain steting due to the elevated Related Compound-C.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- May 11, 2023
- Initial firm notification
- Letter
- Center classification date
- May 15, 2023