methylPREDNISolone Sodium Succinate For Injection recall: Labeling Error
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD…
Why was methylPREDNISolone Sodium Succinate For Injection 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 1901113.1, Exp JUL 2021
- Product
- methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD…
- Recalling firm
- Hikma Pharmaceuticals USA Inc.
- Quantity
- 4840 vials
- Distribution
- Nationwide in the USA
- Recall date
- January 29, 2020
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (drug)