MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL...
FDA Drug Recall #D-0499-2024 - Class II, April 25, 2024
Recall Summary
| Recall Number | D-0499-2024 |
| Classification | Class II - Moderate risk |
| Date Initiated | April 25, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Sagent Pharmaceuticals |
| Location | Schaumburg, IL |
| Product Type | Drugs |
| Quantity | 14,360 vials |
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
Reason for Recall
Presence of Particulate Matter: Potential for black particulates in the drug product.
Distribution Pattern
Nationwide in the USA
Lot / Code Information
Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
Other Recalls from Sagent Pharmaceuticals
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0539-2026 | Class III | Busulfan Injection, 60 mg per 10 mL (6 mg per m... | May 4, 2026 |
| D-0554-2024 | Class I | Docetaxel Injection, USP, 160 mg per 16 mL (10 ... | May 28, 2024 |
| D-0553-2024 | Class I | Docetaxel Injection, USP, 80 mg per 8 mL (10 mg... | May 28, 2024 |
| D-0935-2023 | Class II | Oxacillin for Injection, USP, 1 gram per vial, ... | Jul 11, 2023 |
| D-0936-2023 | Class II | Oxacillin for Injection, USP, 2 grams per vial,... | Jul 11, 2023 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping, abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications, even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications, use a drug take-back program.