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.
Reported: January 29, 2020 Initiated: January 14, 2020 #D-0801-2020
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.
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.
Details
- Recalling Firm
- Hikma Pharmaceuticals USA Inc.
- Units Affected
- 4840 vials
- Distribution
- Nationwide in the USA
- Location
- Cherry Hill, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hikma Pharmaceuticals USA Inc.. Units affected: 4840 vials.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 29, 2020. Severity: Low. Recall number: D-0801-2020.
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