Hospira Recalls Cytarabine Injection Due to Visible Particles in Glass
Hospira is recalling 210 vials of Cytarabine Injection because visible particles embedded in the glass neck 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 particulate contamination in an intravenous drug, which poses a risk of harm even though no specific injuries are reported in the text.
Plain-English summary
Hospira Inc. is recalling 210 vials of Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial. The recall affects specific lots with expiration dates ranging from August 2013 to November 2013. The product is an antineoplastic/cytotoxic agent intended for intravenous use.
The recall was initiated 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 particles, which may become dislodged into the solution. This issue affects Cytarabine Injection as well as Carboplatin Injection, Methotrexate Injection, USP, and Paclitaxel Injection.
The affected product was 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. Healthcare providers and patients should stop using the affected lots and contact Hospira or their local FDA office for further instructions.
The recalled product
- Product
- CYTARABINE (CYTARABINE)
- Brand
- CYTARABINE
- Manufacturer
- Hospira Inc.
- Category
- Drug — Antineoplastic
- Affected units
- 210
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 (9)
- lot numbers Y131994AA
- exp AUG 2013
- Y141994AA
- exp SEP 2013
- Y151994AA
- Y161994AA
- exp NOV 2013
- Y171994AA
- exp NOV 2013 and Y181994AA
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.
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