Tagged Articles

microbial contamination 9 articles

Mylan recalls 2.5M bottles of generic Lipitor due to possible contamination

Mylan Pharmaceuticals Inc., is recalling more than 2.5 million bottles of generic Lipitor, a cholesterol-lowering statin medication known chemically as atorvastatin, due to the potential for microbial contamination. The Food and Drug Administration (FDA) has listed the issue as a Class II recall, which involves a situation in which use of or exposure to a violative product may cause temporary or medically reversible health consequences or where the probability of serious adverse health consequences is remote. Affected products were distributed nationally. The recall includes atorvastatin calcium tablets packaged in 90-count or 500-count bottles and include more than 1.2 million 10mg ... Read More

Recall: all sterile products compounded by Wells Pharmacy Network

Wells Pharmacy Network is recalling all sterile human and veterinary products prepared between Feb. 22, 2016, and Sept. 14, 2016, that remain within the expiration date over concerns raised by the Food and Drug Administration (FDA) over sterility assurance. A list of affected products and lot numbers can be found on the company’s press release. Administration of a drug product intended to be sterile that has microbial contamination may result in infections, some of which may be serious and life-threatening, the Food and Drug Administration (FDA) warned. The long list of recalled products were used in a variety of indications ... Read More

Testing shows calcium injections were contaminated with dangerous bacteria

The Food and Drug Administration (FDA) is urging health care professionals to follow up with patients treated with injections of calcium gluconate 10% made by Rx Formulations between Nov. 7 and Dec. 11, 2013. Testing on the product has confirmed the presence of microbial contamination, specifically gram-positive rod bacteria, which could cause adverse health consequences and possibly serious infection. Calcium gluconate is used to treat calcium deficiency and postmenopausal osteoporosis. It also treats black widow spider bites, lead colic, overdose of magnesium or certain heart medicines, and a condition called rickets. It is also used in life support and life-threatening ... Read More

FDA warns that nasal spray from The Compounding Shop may be contaminated with fungus

The Food and Drug Administration (FDA) is warning patients and health care providers that budesonide solution, used for nasal irrigation, from The Compounding Shop of St. Petersburg, Fla., may be contaminated and should not be used or administered to patients. Visible, white floating material was observed in a 1000mL bottle of the nasal spray and was later identified as a fungus. The FDA is concerned that other budesonide solution products from The Compounding Shop may be contaminated. Budesonide solution is labeled “for inhalation only.” Oral inhalation products, such as budesonide solution, are required to be sterile. Contaminated drug products, whether ... Read More

Baby, kids sunscreens recalled due to microbial contamination

W.S. Badger Company is recalling all lots of its 4-ounce SPF 30 Baby Sunscreen Lotions and one lot of its 4-ounce SPF 30 Kids Sunscreen Lotion due to microbial contamination. The products were tested and found to be contaminated with Pseudomonas aeruginosa, Candida parapsilosis and Acremonium fungi. No adverse events have been associated with this recall. The sunscreens are sold in the United States and Canada online and at major retailers as well as independent food co-ops and pharmacies. The product can be identified by matching the UPC with the Lot Code, which can be found on the top front ... Read More

FDA inspection of laboratory uncovers microbial contamination, results in drug recalls

A recent Food and Drug Administration (FDA) inspection of Front Range Laboratories in Loveland, Colo., found microbial contamination in products intended to be sterile and has led to several recalls. If these tainted drug products are administered to patients, they could cause serious and potentially life-threatening infections. Front Range Laboratories has contracts with other drug companies, including JCB Laboratories and Wellness Pharmacy Inc. The following JCB Laboratories compounded products are subject to the recall: Sodium thiosulfate, 25% (250 mg/mL); Sodium citrate, 4% solution for injection; Sodium citrate, 4% with gentamicin 320 mcg/mL solution for injection; and Acetylcysteine, 20% solution for ... 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

FDA inspection of pharmacy at center of meningitis outbreak uncovers numerous violations

Federal officials conducting an investigation into the specialty pharmacy that made contaminated steroid shots that resulted in a deadly multistate fungal meningitis outbreak have identified problems with the pharmacy’s ability to maintain its clean room, the sterile space where drug ingredients are custom mixed. “Production of sterile drug products in a properly functioning and maintained clean room reduces the risk of the introduction of microbial contamination into the drug during processing, including filling into its final container,” the investigators said in their report. Investigators have confirmed that injectable steroids made by New England Compounding Pharmacy (NECC) in Framingham, Mass., contained ... Read More

Disinfectant, antiseptic swabs and wipes recalled due to possible contamination

Selected lots of benzalkonium chloride swabs and antiseptic wipes manufactured for DUKAL by Jianerkang Medical Dressing Co. and sold over-the-counter and in kits are being recalled because of potential microbial contamination with Burkholderia cepacia. All customers are advised to discontinue use of the recalled products immediately as using them could lead to infections, some of which pose certain health risks for immune-suppressed patients. Burkholderia cepacia is an important human pathogen that often causes pneumonia in people with underlying lung diseases such as cystic fibrosis or chronic granulomatous disease. For average healthy people, the presence of Burkholderia cepacia on the recalled products ... Read More