Baxter Recalls More Heparin Products

Mar 05, 2008
By Pharmaceutical Executive Editors

Last week, Baxter widened its recall net of blood thinner Heparin to include single-dose vials and Heparin lock flush products, both of which include the active ingredient that might have killed four people and affected hundreds more.

The drug manufacturer previously recalled only multi-dose vials of the drug but has expanded the recall as a precautionary measure, according to a release. FDA had requested that the company hold off on completely pulling all forms Heparin until a substitute could be found for patients currently using the medication. Stated Peter J. Arduini, president of Baxter's Medication Delivery business: "We have assurance from the US Food and Drug Administration that there is an adequate supply in the market to meet the demand for these critical and lifesaving drugs."

The alternative supplies will come from Baxter rival APP Pharmaceuticals, which makes a generic anticoagulant. reports that APP has already seen a boost in profits since the recall and that this could be a boon to the company that splits the market with Baxter nearly fifty-fifty.

"While the Chinese-sourced active pharmaceutical ingredient [API] in Baxter's heparin has been singled out as the most likely culprit behind the adverse events, this remains to be seen, as does Baxter's ability to quickly rectify any API-quality issue," Elliot Wilbur, analyst with Oppenheimer & Co, told "Baxter's problems are an opportunity for APP."

Pharm Exec previously reported that nine lots of the drug had been recalled due to severe allergic reactions and other adverse effects including vomiting and difficulty breathing. More than 350 people have reported severe side effects in 2008.

The source of the problem appears to be a Chinese manufacturing plant that supplies Baxter with one of the drug's key ingredients. Last week, FDA visited the plant and found a number of violations including:

  • Incomplete manufacturing instructions
  • Lack of critical processing steps or annual test results
  • Lack of an impurity profile for Heparin
  • Incomplete manufacturing instructions for Heparin Sodium USP
  • Investigations into failed lots were approved as complete, but no cause was listed
  • Inadequate control of material flow in the processing area

An FDA-483 letter was given to the Chinese manufacturer listing all problems and violations.

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