Hospira Recalls Carboplatin Injection Vials Due to Visible Crystals
Hospira is recalling 31,326 vials of Carboplatin Injection due to visible crystals found during inspection. The product is distributed nationwide and in Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.
Plain-English summary
Hospira Inc. is recalling 31,326 vials of Carboplatin Injection, 450 mg/45 mL (10 mg/mL). The product is a sterile, multi-dose vial intended for intravenous use and is available under NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label). The affected lots are Z011711AA and Z011711AB, with an expiration date of 08/2013.
The recall was initiated because visible particulates were identified during a retain sample inspection. These particles were identified as Carboplatin crystals. The product was distributed nationwide and in Puerto Rico.
Healthcare providers and patients should stop using the affected vials and contact Hospira Inc. for further instructions. This is a prescription-only medication used as a cytotoxic agent.
The recalled product
- Product
- CARBOPLATIN (CARBOPLATIN)
- Brand
- CARBOPLATIN
- Manufacturer
- Hospira Inc.
- Category
- Drug — Antineoplastic
- Affected units
- 31,326
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 (2)
- lots Z011711AA (Hospira label) and Z011711AB (Novaplus label)
- Exp. 08/2013
Distribution
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
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