All nonexpired products made by Coastal Meds LLC, of Biloxi, Mississippi, that are marketed as sterile have been recalled, owing to visible particles in some of the drug vials for injection, the US Food and Drug Administration (FDA) advised in an April 13 alert to healthcare professionals.
A recent FDA inspection of Coastal Meds found “visible particulates and poor sterile production practices,” raising concerns about particulates in Coastal Meds’ drug products intended for injection, the agency said.
On April 5, Coastal Meds initiated a voluntary recall of all products intended to be sterile. The FDA asked the company to inform the public of the recall, but they failed to do so, according to the FDA, which prompted the FDA alert to healthcare providers to dispose of and to stop administering sterile injection drug products produced and distributed by Coastal Meds.
“Injection of a drug product containing particulate matter may result in serious and potentially life-threatening adverse events, such as infection, allergic reaction, toxicity, or other reactions,” the FDA said.
A copy of the inspection report cites a series of violations, including inadequate aseptic processing areas and a lack of protective apparel to prevent contamination of drug products. The report also cites the company for deficient product labels.
“Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use. Specifically, stability studies have not been initiated for all injectable drug products to support their 6-month (180-day) expiration date,” the report states. It lists several injectable vitamin products that have been made and distributed without stability studies having been initiated/performed, including but not limited to hydroxocobalamin, cyanocobalamin, methylcobalamin, and pvridoxine. L-Carnitine for injection is also on the list.
The FDA advises healthcare professionals to check their medical supplies, quarantine any sterile injection drug products from Coastal Meds, and not administer them to patients. “Healthcare professionals should make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards,” the FDA said.
To date, the agency has not received any reports of adverse events associated with drug products produced by Coastal Meds.
The FDA encourages healthcare professionals to report adverse reactions or quality problems with these 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://ift.tt/KHxbBZ; with postage-paid FDA form 3500, available at https://ift.tt/1412xto; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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