The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-153-2013·Announced 2013-02-13

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.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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
Hazard
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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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

Same brand · CARBOPLATIN

Same manufacturer · Hospira Inc.

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Same hazard · crystallization

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