Reported Dec 4, 2013 · Terminated
PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple Dose Vial;(NDC 63323-763-50); Rx Only;…
Fresenius Kabi USA, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 3 Corporate Dr · Lake Zurich, IL · 60047-8930
Is this the product you have?
- 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
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 Lot # 871ZA00201, Exp 11/13 2 Lot # 871ZA00301, Exp 11/13 3 Lot # 871ZA00302, Exp 11/13 4 Lot # 871ZA00401, Exp 11/13 5 Lot # 871ZA00402, Exp 11/13 6 Lot # 872ZA00101, Exp 12/13 7 Lot # 872ZA00201, Exp 12/13 8 Lot # 872ZA00301, Exp 12/13 9 Lot # 872ZA00401, Exp 12/13 10 Lot # 872ZA00501, Exp 12/13 - Amount recalled
- 71,129 vials
Where it was sold
- Nationwide
- PR
Why it was recalled
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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