Mansfield, MAThe heparin scare appears to be reaching crisis proportions as yet another manufacturer has recalled dozens of lots of its pre-filled syringes after a heparin-like contaminant was found in tested heparin.
Covidien announced the voluntary recall March 28th of 32 lots of Heparin Lock Flush Syringes containing various concentrations of heparin. The recall, announced in concert with the US Food and Drug Administration (FDA), comes on the heels of similar recalls by Baxter International, and B. Braun.
The most telling aspect of this latest recall, however, is the identity of Covidien's supplier--Scientific Protein Laboratories LLC—the same supplier implicated in the two prior recalls.
A Wisconsin-based company, Scientific Protein Laboratories (SPL) operates a facility in China that refines crude heparin obtained from consolidators, who in turn source the material from various suppliers, many of them unregulated.
The initial recall by Baxter came amidst hundreds of reports of adverse reactions to heparin, and the potential for 19 deaths that may have been linked to heparin products. The FDA noted at the time that while standard testing methods turned up nothing sinister in the suspected heparin, advanced testing techniques identified an unknown heparin-like contaminant, which was found to be present in terms of volume, at concentrations of 20 percent to 50 percent of actual heparin, in heparin solution.
Further scrutiny concluded that the mystery mimic was oversulfated chondroitin sulfate. Yet to be determined is why this heparin mimic was put into the mix, and what effect it has on the health of heparin patients.
However, at the time of the massive Baxter recall earlier in the year, industry insiders were confident that even with the size of the Baxter market—Baxter has a huge footprint in the global heparin market—there would be sufficient supply to take up the slack, until the whole mess was sorted out.
Then came the B Braun heparin recall, followed a few weeks later by this latest recall announced in late March. Covidien has indicated they have received no adverse reaction reports with regard to its heparin products, but decided to initiate the voluntary recall as a precaution after it was notified by SPL that "two lots of Heparin Sodium USP Active Pharmaceutical Ingredient acquired by Covidien contained a heparin-like contaminant," according to information posted on the FDA web site.
No further information was issued by SPL as to the source of the contaminated heparin. However, an SPL-owned plant in China, known as Changzhuo SPL, has been linked to both the Baxter and B. Braun recalls, and SPL has confirmed that the tainted heparin has been found at its China facility. The current investigation centers on the supply chain going to Changzhuo SPL.
While the FDA and various other players grapple with the China connection, including a huge and largely unregulated cottage industry that fashions crude heparin in often crude conditions from the intestines of pigs, the larger question is how many fingers does SPL have in the heparin pie? So far, three of the largest recalls of tainted heparin have been linked to Scientific Protein Laboratories. One has to wonder how many other pharmaceutical companies source their refined heparin from SPL, and if there will be more recalls in the offing?
Beyond that, with China having been granted such a large supply footprint in the heparin world, what would this do to the global supply, if more heparin is found to be tainted, or potentially so?
Stay tuned. For a complete listing a recalled Covidien (formerly known as Tyco Healthcare) heparin pre-filled syringes, visit visit here.
Typical symptoms of adverse reaction to tainted heparin include anaphylactic-like responses such as low blood pressure, shortness of breath, nausea, vomiting, diarrhea and abdominal pain.