Drug Enforcement D-0499-2024

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

Status

Ongoing

Classification

Class II

Report Date

May 22, 2024

Termination Date

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Product Information

Product description
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
Product quantity
14,360 vials
Reason for recall
Presence of Particulate Matter: Potential for black particulates in the drug product.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Sagent Pharmaceuticals
Address
1901 N Roselle Rd Ste 450, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0499-2024
Event ID
94486
Recall initiation date
April 25, 2024
Center classification date
May 15, 2024
Code info
Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
More code info
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