Don't Use Any Medications From This Company Right Now, FDA Warns
The products could pose serious health and safety risks to anyone who uses them, experts say.
Taking a new medication can make anyone nervous. You may be worried about side effects, potential interactions, or just about whether or not your new medication will actually work. In the case of medications from one major manufacturer, however, those may be the least of your concerns, unfortunately. The U.S. Food & Drug Administration (FDA) has just announced that customers should stop using any medications from this particular company due to the serious—and potentially deadly—safety risks they may pose. Read on to find out if your medication is affected and what to do if you have the recalled products at home.
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Edge Pharma, LLC has recalled all of its medications.
On Dec. 7, the FDA announced that Edge Pharma, LLC had initiated a voluntary recall of all of its compounded medications.
The affected products, which were distributed throughout the U.S. to medical facilities and directly to customers, include products "packaged in Containers, IV bags, Syringes, Drop containers, Vials, Bottles, and Jars." The affected medications can be identified by the Edge Pharma, LLC name and logo printed on a label affixed to each product.
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Over 60 products are included in the recall.
The massive recall includes a wide variety of both sterile- and non-sterile medications produced by Edge Pharma, LLC. The affected sterile medications include aluminum potassium sulfate, buffered lidocaine, ceftazidime, cefuroxime, dexamethasone phosphate, edetate disodium, epinephrine/lidocaine HCL, gemcitabine, glycerin, lidocaine HLC/bupivacaine HCL/hyaluronidase, methacholine challenge 5-syringe test kits, methacholine chloride, methotrexate, mitomycin irrigation, mitomycin-C, moxifloxacin HCL, Mvasi, neostigmine methylsulfate, norepinephrine bitartrate, phenol, phenylephrine/tropicamide/ketorolac/ciprofloxacin, phenylephrine HCL, phenylephrine/cyclopentolate/tropicamide/ketorolac, povidone-iodine, trypan blue, vancomycin HCL, and prescription allergy treatment sets.
The non-sterile products affected by the recall include benzocaine/lidocaine/tetracaine, cantharidin, ciprofloxacin/sulfacetamide sodium/amphotericin B, ciprofloxacin/sulfacetamide sodium/amphotericin B/hydrocortisone, dexamethasone iontophoresis, dibutyl squarate, lidocaine/tetracaine, lidocaine/epinephrine/tetracaine HCL, lidocaine HCL/oxymetazoline, lidocaine HCL/prilocaine HCL/tetracaine HCL in raspberry marshmallow and mint for dental use, lidocaine HCL/prilocaine HCL/tetracaine HCL/phenylephrine HCL in raspberry marshmallow and mint for dental use, phenol, phenylephrine HCL/lidocaine HCL, phytonadione, promethazine HCL, tetracaine HCL, and vancomycin HCL. All of the product concentrations, sizes, and NDC numbers of the recalled medications are available on the FDA recall page.
The products could potentially pose a fatal health risk.
The recall was initiated after it was discovered that the products may not be sterile and thus might not be safe for use by consumers.
"Administration of a drug product intended to be sterile, that is not sterile, could result in site specific infections as well as serious systemic infections which may be life-threatening," Edge Pharma explains. However, at the time the recall was announced, the company had not received any reports of illness or other health issues associated with the use of the recalled medications.
If you have the medications at home, don't use them.
If you are in possession of any of the recalled medications, stop using them immediately and contact your healthcare provider to seek alternate treatment options.
The affected products can be returned or disposed of; Edge Pharma is also contacting customers via email and other methods of direct outreach, as well as publishing additional information through the FDA and the company's website as it becomes available. If you have questions related to the recall, contact Edge Pharma at 802-992-1178 on weekdays from 8 a.m. to 4 p.m. EST or via email at [email protected]
If you believe you've experienced health issues associated with the use of the recalled medications, contact a healthcare provider immediately.
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