Tagged Articles

sterility 7 articles

Lawsuits allege Mirena IUD caused brain damage

“I was one of the lucky ones,” writes “Proud Mama Fighting Back,” who describes herself as a “post Mirena survivor,” and chronicles her “Mirena nightmare” on her blogspot site, MyLifeAfterMirena. She says she was lucky because after having the Mirena intrauterine device inserted, she lost most of her vision in her right eye after two months. “I went from great vision to legally blind in that eye virtually overnight,” she writes. That’s when the blogger learned about a connection between the Mirena IUD and pseudo tumor cerebra (PTC), also known as idiopathic intracranial hypertension (IIH), a type of brain damage in which too ... Read More

Compounding pharmacy issues recall of prescription vitamin products

A Food and Drug Administration (FDA) inspection of a compounding pharmacy laboratory has resulted in a recall of B12 and neonatal vitamins to the consumer level. Park Pharmacy & Compounding Center is recalling two lots of Methylocobalamin (5mg/ml 30ml Amber Vials Lot #06132013@1 Exp: 12/10/2013) and Multitrace-5 Concentrate (10ml Amber Vials Lot #05212013@20 Exp: 11/17/2013 for injection) after FDA inspectors observed methods used by the laboratory to assess the sterility of the products may have resulted in pharmacies receiving inaccurate laboratory test results. The agency is concerned that the results obtained from the laboratory are not reliable. The prescription preparations ... Read More

Another compounding pharmacy recalls all products due to sterility issues

All sterile products made by Beacon Hill Medical Pharmacy d/b/a Rxtra Solutions, a compounding pharmacy in Southfield, Mich., have been recalled because the Food and Drug Administration (FDA) has raised questions about the sterility of the products. Microbial contamination of products that are intended to be sterile can cause serious infections that can be life threatening. To date, there have been no reports made to Beacon Hill of any adverse reactions related to the recall, nor has any evidence of contamination been found in the recalled products or any products previously prepared by the pharmacy. The recall affects more than ... Read More

Hepatitis B vaccine recalled due to sterility issues

Vials of the hepatitis B vaccine RECOMBIVAX HB are being recalled by the manufacturer because a limited number of the vials in the lot may crack, the Food and Drug Administration (FDA) announced. If a crack occurs, the integrity of the vial and the sterility of any product remaining in the vial could not be assured. Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., issued the recall for Lot Number J001183 of RECOMBIVAX HB (Recombinant) Adult Formulation. The product was distributed only in the United States between March 12, 2013, and May 2, 2013. The company says ... Read More

Compounding pharmacy recalls products due to mold contamination

Med Prep Consulting, Inc., a compounding pharmacy based in Tinton Falls, NJ, is recalling all products after mold was discovered floating in plastic infusion bags. The mold was discovered in five bags of magnesium sulfate 2GM in Dextrose 5% in water, 50ml for injection, a product used for magnesium electrolyte replacement. If an intravenous product found to contain mold is injected into a patient, it could have deadly results. In an abundance of caution, Med Prep Consulting has recalled all products compounded by the pharmacy due to lack of sterility assurance. The affected products are administered for a wide range ... Read More

CDC reports more infections, deaths from multistate fungal infection outbreak

Nearly 600 people have become infected by a fungus from contaminated steroid shots made by a compounding pharmacy, and 37 have died, according to the Centers for Disease Control and Prevention (CDC). The CDC has been updating the number of people infected on a weekly basis, and is reporting 49 new cases of infection and one additional death since last Monday. Everyone infected received at least one injection from thee lots of a preservative-free methylprednisolone acetate (MPA), a steroid shot that is commonly injected into the spinal cord to relieve back or neck pain, or into joints such as the ... Read More

Sterility concerns lead to recall of all products from another compounding pharmacy

The Food and Drug Administration (FDA) has ordered the recall of all unexpired products made by Ameridose, LLC, a compounding pharmacy based in Westborough, Mass., after an inspection of the facility raised concerns about sterility. The recall comes in the wake of a deadly multistate fungal meningitis outbreak that was traced back to steroid shots made by a different compounding pharmacy. The investigation is ongoing and there have been no reports of patients with infections with any of Ameridose’s products; however, health inspectors say a recall of the products was ordered out of an abundance of caution. “Use of non-sterile ... Read More