Why it was recalled
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
Product description
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.
Lot numbers, UPCs & expiration codes
Lot #: 1901113.1, Exp JUL 2021
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-0801-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jan 14, 2020
- FDA report date
- Jan 29, 2020
- Quantity
- 4840 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
Original FDA data
Every field from FDA enforcement report D-0801-2020, exactly as published.
Show all FDA fields
- City
- Cherry Hill
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84676
- Address
- 2 Esterbrook Ln
- Code information
- Lot #: 1901113.1, Exp JUL 2021
- Postal code
- 08003-4002
- Report date
- Jan 29, 2020
- Product type
- Drugs
- Recall number
- D-0801-2020
- Classification
- Class III
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Product quantity
- 4840 vials
- Termination date
- Sep 8, 2021
- Reason for recall
- Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jan 14, 2020
- Initial firm notification
- Letter
- Center classification date
- Jan 23, 2020