PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323...
FDA Drug Recall #D-016-2014 — Class III — November 8, 2013
Recall Summary
| Recall Number | D-016-2014 |
| Classification | Class III — Low risk |
| Date Initiated | November 8, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Fresenius Kabi USA, LLC |
| Location | Lake Zurich, IL |
| Product Type | Drugs |
| Quantity | 71,129 vials |
Product Description
PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only; Manufactured for APP Pharmaceuticals, LLC; Schaumburg, IL 60173; Made in India
Reason for Recall
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Distribution Pattern
US: Nationwide and Puerto Rico
Lot / Code Information
Lot # 871ZA00201, Exp 11/13 Lot # 871ZA00301, Exp 11/13 Lot # 871ZA00302, Exp 11/13 Lot # 871ZA00401, Exp 11/13 Lot # 871ZA00402, Exp 11/13 Lot # 872ZA00101, Exp 12/13 Lot # 872ZA00201, Exp 12/13 Lot # 872ZA00301, Exp 12/13 Lot # 872ZA00401, Exp 12/13 Lot # 872ZA00501, Exp 12/13
Other Recalls from Fresenius Kabi USA, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0432-2026 | Class II | 0.9% Sodium Chloride Injection, USP 900 mg per ... | Mar 11, 2026 |
| D-0427-2026 | Class II | 0.9% Sodium Chloride Injection, USP, (2,250 mg ... | Mar 11, 2026 |
| D-0434-2026 | Class II | 0.9% Sodium Chloride Injection, USP 900 mg per ... | Mar 11, 2026 |
| D-0428-2026 | Class II | 0.9% Sodium Chloride Injection, USP, (4,500 mg ... | Mar 11, 2026 |
| D-0424-2026 | Class II | 0.45% Sodium Chloride Injection, USP, 1.125 gra... | Mar 11, 2026 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced 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.