FDA-Drug2013-12-04Class III
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
Fresenius Kabi USA, LLC
Hazard
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Sold states
US: Nationwide and Puerto Rico
Affected count
71,129 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-016-2014Don't want to check this manually?
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