Recalls / Class III
Class IIID-016-2014
Product
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
- Brand name
- Paclitaxel
- Generic name
- Paclitaxel
- Active ingredient
- Paclitaxel
- Route
- Intravenous
- NDC
- 63323-763
- FDA application
- ANDA077574
- Affected lot / code info
- 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
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.
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 71,129 vials
- Distribution pattern
- US: Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2013-11-08
- FDA classified
- 2013-11-22
- Posted by FDA
- 2013-12-04
- Terminated
- 2015-05-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-016-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.