Status
Terminated
Drug Enforcement D-016-2014
Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
Classification
Class III
Report Date
December 4, 2013
Termination Date
May 12, 2015
Product Information
- 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
- Product quantity
- 71,129 vials
- Reason for recall
- Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinical Studies" and "Specific Adverse Events" sections.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- US: Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Fresenius Kabi USA, LLC
- Address
-
3 Corporate Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-016-2014
- Event ID
- 66810
- Recall initiation date
- November 8, 2013
- Center classification date
- November 22, 2013
- 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
- More code info
- —