The Recall Desk
SevereFDA (Drugs)·D-1679-2012·Announced 2012-09-26

Hospira Recalls Carboplatin Injection Due to Embedded Glass Particles

Hospira Inc. is recalling Carboplatin Injection vials because visible particles are embedded in the glass neck, posing a risk of dislodging into the solution.

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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of physical contamination (glass particles) in an intravenous antineoplastic drug.

Plain-English summary

Hospira Inc. is recalling specific lots of Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vials. The recall also affects Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection. The affected products are antineoplastic/cytotoxic agents manufactured for Hospira, Inc., in Lake Forest, IL, and are products of Australia.

The recall is being conducted because visible particles are embedded in the glass located at the neck of the vials. There is a potential for the product to come into contact with these embedded particles, which may become dislodged into the solution. The recall covers 30,582 vials of Carboplatin Injection.

The affected products were 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. Specific lot numbers and expiration dates are listed in the official recall notice. Healthcare providers and patients should stop using the affected lots and contact Hospira Inc. for further instructions.

The recalled product

Product
CARBOPLATIN (CARBOPLATIN)
Brand
CARBOPLATIN
Manufacturer
Hospira Inc.
Category
Drug — Antineoplastic
Hazard
Affected units
30,582

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 (20)

  • lot numbers Y061711AA
  • exp FEB 2013 and Y061711AB
  • exp FEB 2013 rest of world lots being recalled: list M1685A001
  • lots numbers Y151686AB
  • exp MAY 2013 and Y131686AA
  • exp MAR 2013
  • list M1723A001
  • lot number Y121686AF
  • exp SEP 2013
  • list M1686ADE1
  • lot numbers Y121686AA
  • exp SEP 2013 and Y151686AC
  • exp NOV 2013
  • list M1686AFR1
  • lot numbers Y121686AG
  • exp SEP 2013 and Y131686AB
  • list M1714A001
  • lot number Y121686AC
  • list M1686ANO3
  • lot number Y121686AE

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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

Same brand · CARBOPLATIN

Same manufacturer · Hospira Inc.

See all →

Same hazard · physical contamination

See all →