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
Reported: December 4, 2013 Initiated: November 8, 2013 #D-016-2014
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.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 71,129 vials
- Distribution
- US: Nationwide and Puerto Rico
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Kabi USA, LLC. Units affected: 71,129 vials.
Why was this product recalled? ▼
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 4, 2013. Severity: Low. Recall number: D-016-2014.
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