Reported Jan 29, 2020 · Terminated
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL),…
Hikma Pharmaceuticals USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hikma Pharmaceuticals USA Inc. · 2 Esterbrook Ln · Cherry Hill, NJ · 08003-4002
Is this the product you have?
- methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only
- Mfd byHIKMA FARMACEUTICA (PORTUGAL), SA
- Dist byWEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01
- Lot codes and dates
Lot #: 1901113.1Exp JUL 2021
- Amount recalled
- 4840 vials
Where it was sold
- Nationwide
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.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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