New FDA Report on Unsanitary Manufacturing Conditions at Ameridose

A new report by the Food and Drug Administration describes a long list of unsafe practices and unsanitary conditions at Ameridose, a drug supplier with some of the same owners as the pharmacy that produced contaminated products linked to a nationwide outbreak of fungal meningitis.

Ameridose has been a major supplier of sterile injectable medications to hospitals and sells more than 2,200 blended drug products. The list includes drugs to help women in labor, calm children before surgery, treat severe asthma attacks and provide anesthesia during outpatient surgery. Ameridose recalled all of its products on Oct. 31, and its operations have been suspended. No infections have been linked to Ameridose products to date, an FDA spokesman told The New York Times.

Ameridose was founded in 2006 by Greg Conigliaro and Barry Cadden, who previously had opened the New England Compounding Center, the pharmacy linked to the contaminated steroid medications. About 440 people have been sickened by contaminated steroid shots distributed by NECC and more than 32 deaths have been reported since the outbreak began in September, according to the Centers for Disease Control and Prevention.

The FDA began investigating Ameridose because of its shared ownership history with NECC, which has been closed since last month. In the 20-page report, FDA inspectors reported finding drug solutions contaminated with germs, unsanitary equipment and conditions that demonstrated the firm could not assure that their injectable products were sterile and safe.

The FDA said the company had neglected to adequately investigate complaints of serious reactions in patients, including fetal distress, a hyperstimulated uterus and maternal hemorrhaging from a drug used in labor and breathing problems with fentanyl, a powerful narcotic. The reactions may have been caused by variations in drug potency. When doctors contacted Ameridose to report problems with the company’s drugs, the complaints were not classified as adverse events.

In at least 58 instances, when Ameridose staff found contamination with bacteria and fungi in supposedly sterile liquids used to make up pain relief and anesthetic injections, the company didn’t investigate, the report said.

If you believe that you have been harmed by an injectable steroid medication, contact an attorney knowledgeable about defective drugs and unsafe pharmaceuticals.

The lawyers of The Driscoll Firm, LLC, are committed to helping people who have been harmed by unsafe drugs and pharmaceutical manufacturers that put profits ahead of patient safety. We have helped thousands of clients nationwide receive full and fair compensation from pharmaceutical companies and medical device manufacturers whose products cause harm. If you suspect that you or a loved one has been harmed by an unsafe drug, contact us at 314-932-3232 or use our online contact form for a free case review.

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