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article imageGreen Valley Drugs: Recall of all sterile products

By Tim Sandle     Apr 12, 2013 in Health
The FDA have stated that the pharmacy company Green Valley Drugs has issued a recall notice for all of its products intended to be sterile.
The alert comes via the U.S. Food and Drug Administration (FDA) Medwatch service. The message indicates that Green Valley Drugs notified healthcare professionals and their organizations about the recall of all lots of all sterile products compounded, repackaged, and distributed by the pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
This follows on from reports on the Digital Journal about similar recalls affected Med Prep in New Jersey and Clinical Specialties in Augusta.
Green Valley Drugs is located in Henderson, Nevada. Scot Silber, president and chief executive officer of the company, has told Medscape Medical News that: "Recall letters are going out today; none of the product has been returned yet", emphasising that "this is a quality assurance issue not a sterility issue. Every sterile test for every batch tested has come back sterile."
The recall was due to the outcome of an inspection by Federal authorities. The agency made observations of cleanroom personnel and certain aseptic techniques, which caused concern. It is noted that these are potential concerns given that Green Valley has received no reports of injury or illness associated with the use of the products.
The company has posted up a list of affected medicines via its website. 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.
The FDA has advised that, until further notice, healthcare providers should stop using all lots of sterile products and return them to the company.
There have been several contamination concerns related to pharmacies in the U.S., as the Digital Journal has been reporting on over the past six-months. This includes the New England Compounding Center, where quality deficiencies were linked with patient deaths.
More about green valley, Pharmacy, compounding pharmacy, Sterile, Medicines
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