Recall: D-0499-2024

Class II - Potentially Harmful

Class IIClassification

2024-04-25Initiated

OngoingStatus

Sagent PharmaceuticalsFirm

Product

MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10

Reason

Presence of Particulate Matter: Potential for black particulates in the drug product.

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.