Nearly 4,000 pharmaceutical products recalled by Wedgewood Pharmacy
Veterinary practices are advised to check compounded drug inventory and quarantine any affected products
By Ashley Mayrianne Champagne and Malinda Larkin
Wedgewood Pharmacy has issued a recall of almost 4,000 compounded veterinary products after finding the medications may not contain the correct levels of active ingredients, either being weaker or stronger than their labels indicate.
Compounded medications are those that have been manipulated to change the standard dosage form and meet an individual patient’s therapeutic needs. Administering too little of a drug may result in ineffective treatment, or in the case of too much of the drugs, toxicity or overdose.
The recall applies to products shipped nationwide between February 18 and October 6 based on the company’s investigation of the affected testing data and the expiration dates of affected products. It covers multiple dosage forms, concentrations, and sizes, according to the company’s announcement.
Affected products range from powders, pastes, and oral suspensions to ophthalmic ointments and gels, ear solutions, and topical sprays and gels. While the medications may be used in a range of aquatic, companion, equine, exotic, wildlife, and zoo animals, they are not intended for use in food animals, Wedgewood said.
The products were distributed to veterinary practices, pharmacies, and individual clients. Based in Swedesboro, New Jersey, Wedgewood partners with major retailers and online pharmacies, such as Allivet, Chewy, Vetcove, and Vetsource, to provide compounding services.
Product issues
As of October 21, the company had received 98 complaints associated with the recalled products, seven of which have been described as serious. These complaints represent approximately 0.04% of prescriptions for the recalled products, said Dr. Rae Hutchins, Wedgewood’s chief veterinary officer.
“Under Wedgewood’s internal reporting criteria, a complaint is initially classified as serious when the reported event involves an animal requiring veterinary evaluation or care. This classification reflects the nature of the reported event, not a determination that the medication caused it,” Dr. Hutchins told AVMA News.
The five products with lots most affected are:
- Fluoxetine hydrochloride (HCl) 10 mg per mL oral suspension 30 mL: 1,573 lots
- Fluoxetine (HCl) 5mg per mL suspension 30 mL: 1,309 lots
- Ursodiol 100 mg per mL oral suspension 30 mL: 1,005 lots
- Pimobendan 5 mg per mL oral suspension 30 mL: 991 lots
- Pimobendan 2.5 mg per mL oral suspension 60 mL: 779 lots
According to Wedgewood’s website, the recall was initiated voluntarily after the company identified inconsistencies in its testing data through its own quality assurance program. This includes analytical testing of compounded preparations, such as potency testing, which confirms a preparation contains the intended amount of active ingredient, Dr. Hutchins said.
“The issue we identified involves the reliability of certain analytical testing data used to confirm product quality, rather than a specific problem identified in the manufacturing process,” she said. “We’re working with independent experts and third-party laboratories to better understand what caused the inconsistencies, assess our testing methods and make any necessary improvements. That review is ongoing, and we have not yet reached a final conclusion about the underlying cause.”
The Food and Drug Administration (FDA) is aware of the recall.
Customer information
The company’s website states that veterinary practices and pharmacies that received impacted products will receive an official recall notice either by email or mail with further instructions. Wedgewood has also created a webpage to search for recalled products.
Wedgewood advises veterinary practices, pharmacies and other customers to immediately examine their inventory, quarantine any affected product, and refer to the information in their recall notice or contact Wedgewood’s recall services by phone at 866-562-5931. Veterinary practices or pharmacies that have dispensed any affected products are advised to identify and notify their customers of the recall.
Recall notices are being sent to email addresses on file, according to an FAQ on the recall site. If no email address is available, notices were mailed to pet and animal owners via U.S. Postal Service and to veterinary practices, pharmacies and other customers via UPS ground service.
Wedgewood said it is working to help customers, veterinarians, and pet owners identify clinically appropriate alternatives where available. Wedgewood has also partnered with a third-party company, Sedgwick, to coordinate refunds or replacements of recalled medications where possible.
Individual animal owners can fill out an online form. They will be asked to provide the lot number and a photo of the medication bottle or a copy of their receipt. Veterinary and pharmacy customers are instructed to share the lot numbers and quantities of any affected products they have on hand and return the recall response form provided with their official recall notice. Once their refund is processed, they may safely dispose of the product, Dr. Hutchins said.
“We recognize the challenges this recall has created for veterinary practices and the pet owners who depend on these medications. Helping veterinarians maintain continuity of care for their patients is a top priority,” she added.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA by calling 1-888-FDA-VETS or visiting the FDA website.
Fonte: https://www.avma.org/
