FDA Warns Against Products From The Compounding Shop
Healthcare providers should not administer any
products produced by The Compounding Shop of St. Petersburg, Florida,
the US Food and Drug Administration (FDA) advised today.
During a recent inspection of the facility, FDA inspectors observed "poor sterile production practices that raise concerns about a lack of sterility assurance of The Compounding Shop's sterile drug products. Therefore, these products should not be administered to patients," according to the agency.
"If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
"We do not have reports of patient infections. However, due to concerns about a lack of sterility assurance at the facility and out of an abundance of caution, we have advised the firm to remove its sterile products from the market to protect patients," she added.
The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers, the agency said.
The FDA advises healthcare providers and hospital staff to immediately check their medical supplies, quarantine any sterile products from The Compounding Shop, not administer them to patients, and await further instructions from the company regarding the recalled products.
Patients who have received any product produced by The Compounding Shop and have concerns are being advised to contact their healthcare provider.
The problems and product recall involving The Compounding Shop in St.
Petersburg, Florida, comes on the heels of recalls last month at other
compounding pharmacies because of similar problems and concerns about
sterility of products after FDA inspections.
As reported by Medscape Medical News, those companies include ApothéCure Inc and NuVision, Green Valley Drugs, and Balanced Solutions Compounding Pharmacy.
Healthcare professionals and patients are encouraged to report adverse events potentially related to the use of these or other products to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
During a recent inspection of the facility, FDA inspectors observed "poor sterile production practices that raise concerns about a lack of sterility assurance of The Compounding Shop's sterile drug products. Therefore, these products should not be administered to patients," according to the agency.
"If an injectable drug product that is intended to be sterile is contaminated, it could result in a life-threatening infection in patients," Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
"We do not have reports of patient infections. However, due to concerns about a lack of sterility assurance at the facility and out of an abundance of caution, we have advised the firm to remove its sterile products from the market to protect patients," she added.
The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers, the agency said.
The FDA advises healthcare providers and hospital staff to immediately check their medical supplies, quarantine any sterile products from The Compounding Shop, not administer them to patients, and await further instructions from the company regarding the recalled products.
Patients who have received any product produced by The Compounding Shop and have concerns are being advised to contact their healthcare provider.
As reported by Medscape Medical News, those companies include ApothéCure Inc and NuVision, Green Valley Drugs, and Balanced Solutions Compounding Pharmacy.
Healthcare professionals and patients are encouraged to report adverse events potentially related to the use of these or other products to MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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