Hospira Recalls Carboplatin Injection Vials Due to Crystallization
Hospira Inc. is recalling 23,315 vials of Carboplatin Injection due to visible particulates identified as Carboplatin crystals.
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 FDA classified this recall as Class I, which mandates a minimum severity score of 4 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Hospira Inc. is recalling 23,315 vials of Carboplatin Injection, 600 mg/60 mL (10 mg/mL), sterile, multi-dose vials. The product is a prescription-only cytotoxic agent intended for intravenous use. The recall covers Lot # Z021650AA with an expiration date of 08/2013.
The recall was initiated because visible particulates were identified during a retain sample inspection. These particles were confirmed to be Carboplatin crystals. The affected product was distributed nationwide and in Puerto Rico.
Healthcare providers and patients should discontinue use of the affected lot and contact Hospira Inc. for further instructions. This recall is classified as Class I by the FDA.
The recalled product
- Product
- CARBOPLATIN (CARBOPLATIN)
- Brand
- CARBOPLATIN
- Manufacturer
- Hospira Inc.
- Category
- Drug — Prescription Injection
- Affected units
- 23,315
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)
- Lot #: Z021650AA
- 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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FDA (Drugs) · 2012-09-26
- LowHospira Recalls Carboplatin Injection Vials Due to pH Specification Failure
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