FDA officials were busy in the final days of last week as U.S. Marshals under FDA orders seized tainted heparin from Celus Labs in Cincinnati on Thursday. Meanwhile, after three months on market, FDA officials stepped in to help healthcare device manufacturer Covidien recall dangerously mislabeled insulin, a potentially lethal packaging error that has already led to at least one injury.
After the heparin scares earlier this year from FDA-recalled tainted Baxter heparin, I thought Tennessee Law Blog would be finished warning our readers of potential heparin injuries and tainted lots of heparin. Unfortunately, this was not the case as 11 lots of heparin were seized Thursday.
U.S. Food and Drug Administration (FDA) seized 5 lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and 6 lots of Heparin Lithium from Celsus Laboratories Inc. in Cincinnati. These 11 lots were manufactured from Chinese over-sulfated chondroitin sulfate (OSCS), a crude substance that imitates heparin’s blood thinning activity but whose over-sulfated qualities make the injected anticoagulant dangerous to the patient.
To-date, there have been over 13 recalls of tainted Chinese heparin and over 200 deaths connected to the contaminated heparin. (Click for FDA’s complete list of potentially Chinese heparin tainted medical devices.) In April, FDA inspectors found over 30 pounds of contaminated heparin at Celsus Labs used for two of its medical products. Thursday’s raid represents a more aggressive strategy for the FDA.
Meanwhile, FDA officials alerted patients and doctors of an insulin recall of 4,710 boxes of ReliOn Insulin Syringes (each box containing 100 insulin syringes). Insulin syringes labeled for use with U-40 insulin instead were packaged with syringes for U-100 insulin, or 2.5 times the stated dosage. These mislabeled ReliOn Insulin Syringes pose a danger of “hypoglycemia, serious health consequences, and even death,” according to the FDA.
Recalled boxes of syringes applies to ReliOn Insulin Syringes (31 gauge 1 cc) from lot number 813900 having product identification number 38396-0403-02. ID numbers can be found in upper right-hand corner of the syringe box. These syringes were sold through Wal-Mart stores and Sam’s Clubs.
One adverse report related to one of these recalled insulin syringes has been reported to the FDA.
If your ReliOn syringes bear the affected lot number (lot #813900), please take one of the following actions:
* Call ReliOn 866-780-5436 for replacement instructions on recalled insulin syringe.
* Read for replacement instructions at www.relion.com/recall.
* Return the recalled syringes to the pharmacy where purchased for replacements.
If you have been injured by defective drugs, tainted medicines, or a medical error in Tennessee or surrounding states, our personal injury law team at our Nashville law offices would like to help. Contact our TN personal injury team or give us a call at 800-705-2121.