Hospira Recalls Paclitaxel Injection Due to Embedded Glass Particles
Hospira Inc. is recalling Paclitaxel Injection vials because visible particles are embedded in the glass at the neck. The particles may dislodge into the solution.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential dislodgement of glass particles into an intravenous solution, which poses a risk of harm even though no injuries are reported in the source text.
Plain-English summary
Hospira Inc. is recalling Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vials. The recall involves 131,264 vials distributed nationwide, including Puerto Rico and Guam, as well as internationally to Australia, Belgium, Canada, France, Germany, Korea, Malaysia, New Zealand, Norway, Pakistan, Philippines, Portugal, Singapore, Sweden, Thailand, and Vietnam.
The recall is being conducted because visible particles are embedded in the glass located at the neck of the vial. There is a potential for the product to come into contact with these embedded particles, which may become dislodged into the solution. The affected lot numbers are Y096865AA, Y106865AA, Y116865AA, Y126865AA, Y136865AA, Y146865AA, Y156865AA, Y166865AA, Y176865AA, and Y186865AA, with expiration dates ranging from August 2013 to December 2013.
Healthcare providers and patients should check their vials for the specific lot numbers and expiration dates listed above. If the product matches the recalled lots, it should not be used. The source text does not provide specific instructions for disposal or return, but standard recall procedures generally involve contacting the manufacturer or a healthcare provider for guidance.
The recalled product
- Product
- PACLITAXEL (PACLITAXEL)
- Brand
- PACLITAXEL
- Manufacturer
- Hospira Inc.
- Category
- Drug — Antineoplastic
- Affected units
- 131,264
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 (15)
- lot numbers Y096865AA
- exp AUG 2013
- Y106865AA
- Y116865AA
- Y126865AA
- exp SEP 2013
- Y136865AA
- Y146865AA
- Y156865AA
- exp OCT 2013
- Y166865AA
- exp NOV 2013
- Y176865AA
- and Y186865AA
- exp DEC 2013
Distribution
Part of a larger recall action
This product is one of 4 recalled by Hospira Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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