Fresenius Kabi Recalls Paclitaxel Injection Due to Missing Package Insert Text
Fresenius Kabi USA, LLC is recalling 71,129 vials of Paclitaxel Injection because the package insert is missing text in the Clinical Studies and Specific Adverse Events sections.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling defect rather than a direct safety hazard.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 71,129 vials of Paclitaxel Injection, USP (300 mg/50 mL; 6 mg/mL). The product is a multiple-dose vial intended for intravenous use and is manufactured for APP Pharmaceuticals, LLC. The recall is due to a labeling error where the product insert is missing text in the "Clinical Studies" and "Specific Adverse Events" sections.
The affected product is distributed nationwide in the United States and in Puerto Rico. The recall involves specific lots with expiration dates of 11/13 and 12/13. The product is a prescription-only medication classified as a human prescription drug.
Healthcare providers and patients should check their inventory for the affected lot numbers and expiration dates. If the product is found, it should be removed from use and returned to the supplier or the recalling firm. This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- PACLITAXEL (PACLITAXEL)
- Brand
- PACLITAXEL
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 71,129
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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
UPCs (2)
- 0363323763503
- 0363323763169
Distribution
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