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Class II: temporary or reversible health riskOngoing

Sagent Pharmaceuticals MethylPREDNISolone Acetate Injectable Recall

MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL),…

Sagent Pharmaceuticals · Schaumburg, IL

Risk level
Class II
Reported by FDA
May 22, 2024
Recall ID
D-0499-2024
Check your lot numberHow we source this data

Summary

Sagent Pharmaceuticals recalled MethylPREDNISolone Acetate Injectable starting Apr 25, 2024. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0499-2024 on May 22, 2024. Reason: Presence of Particulate Matter: Potential for black particulates in the drug product. Status: Ongoing.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0499-2024
Classification
Class II
Status
Ongoing
Recall initiated
Apr 25, 2024
FDA report date
May 22, 2024
Quantity
14,360 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Sagent Pharmaceuticals

Original FDA data

Every field from FDA enforcement report D-0499-2024, exactly as published.

Show all FDA fields
City
Schaumburg
State
IL
Status
Ongoing
Country
United States
Event ID
94486
Address
1901 N Roselle Rd Ste 450
Code information
Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
Postal code
60195
Report date
May 22, 2024
Product type
Drugs
Recall number
D-0499-2024
Classification
Class II
Recalling firm
Sagent Pharmaceuticals
Product quantity
14,360 vials
Reason for recall
Presence of Particulate Matter: Potential for black particulates in the drug product.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide in the USA
Recall initiation date
Apr 25, 2024
Initial firm notification
Letter
Center classification date
May 15, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0499-2024, published May 22, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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