FDA Recall D-0499-2024

Sagent Pharmaceuticals · Schaumburg, IL

Class II Ongoing 749 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025

Quantity: 14,360 vials

Reason for recall

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

Recall record

Recall number: D-0499-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-04-25
Classified by FDA Center: 2024-05-15
FDA published: 2024-05-22
Recalling firm: Sagent Pharmaceuticals
Firm location: Schaumburg, IL

Drug identification

Brand name(s): METHYLPREDNISOLONE ACETATE
Generic name(s): METHYLPREDNISOLONE ACETATE
Manufacturer(s): Sagent Pharmaceuticals
NDC(s): 25021-820, 25021-821
Route(s): INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRASYNOVIAL, SOFT TISSUE

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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