Green Valley Drugs, in Henderson, Nevada, has voluntarily recalled all lots of all sterile products compounded, repackaged, and distributed by the pharmacy due to "lack of sterility assurance," the company said. The recall of sterile products is based on observations of clean room personnel and certain aseptic techniques.
Scot Silber, president and chief executive officer, told Medscape Medical News, "Recall letters are going out today; none of the product has been returned yet." He emphasized that this is a "quality assurance issue not a sterility issue. Every sterile test for every batch tested has come back sterile."
The US Food and Drug Administration has posted the recall notice on its Web site.
The sterile products covered under the recall were distributed nationwide. A full list of the recalled products and lot numbers, as well as "beyond use date" information, is available here.
The list includes more than 660 lots of various drugs including but not limited to various preparations of acetylcysteine, ascorbic acid, betamethasone, bupivacaine, cyanocobalamin, dexamethasone, edetate disodium, gentamicin, hyaluronidaise, lidocaine, magnesium sulfate, methylcobalamin, methylprednisolone, sodium bicarbonate, testosterone cypionate, triamcinolone acetonide, and zinc sulfate.
"Abundance of Caution"
Green Valley Drugs said they have not received any reports of injury or illness associated with the use of our sterile products. In addition, they have received no indications of endotoxins or sterility issues from independent outside testing laboratories associated with any of the products subject to this recall.
"Out of an abundance of caution and in the interest of our patients, Green Valley Drugs has decided to voluntarily proceed with this recall process," the company said in a statement. "In the event a sterile product is compromised patients are at risk for serious and possible life threatening infections."
"Until further notice, health care providers should stop using all lots of sterile products and return them to the company," the company advised in a statement.
Health providers with questions about the recall are advised to contact Green Valley Drugs by phone at 702-564-2079 or email at email@example.com between 9:00 AM and 5:00 PM PST Monday through Friday.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch adverse event reporting program either 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 https://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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Cite this: Green Valley Drugs Announces Nationwide Recall of Sterile Products - Medscape - Apr 11, 2013.