Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mf...

FDA Drug Recall #D-0554-2024 - Class I, May 28, 2024

Recall Summary

Recall Number D-0554-2024
Classification Class I - Serious risk
Date Initiated May 28, 2024
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Sagent Pharmaceuticals
Location Schaumburg, IL
Product Type Drugs
Quantity 2806 vials

Product Description

Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Dose Vial, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-254-08

Reason for Recall

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.

Distribution Pattern

Nationwide within the USA.

Lot / Code Information

Lot #: F1030001, Exp. Date 12/31/2024

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-0553-2024 Class I Docetaxel Injection, USP, 80 mg per 8 mL (10 mg... May 28, 2024
D-0499-2024 Class II MethylPREDNISolone Acetate Injectable Suspensio... Apr 25, 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.