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Wedgewood召回部分复配兽药:实验室检测数据不可靠,药效可能过低或过高,已收到98起投诉其中7起严重

2026-10-28 · 生活 · GSM News

美国食品药品监督管理局(FDA)10月21日刊出企业召回公告:位于新泽西州格洛斯特县斯威兹伯勒(Swedesboro)的 Wedgewood Pharmacy LLC 正在召回部分在有效期内的复配兽药,原因是其实验室部分分析检测数据的可靠性出现不一致,产品药效可能过低或过高;受影响产品于2026年2月18日至10月6日间发往全美各地的兽医诊所、药房和其他客户,动物主人应停用并保留产品,拨打电话 866-562-5931 联系召回服务。

公告称,召回是在供应商与客户层面进行,问题由 Wedgewood 自身的质量流程发现。受影响剂型包括粉剂、糊剂、口服混悬液、注射剂、眼用软膏与溶液、耳用溶液与混悬液、外用喷雾和凝胶,完整的产品清单、批号和有效期可在 wedgewood.com/recall-lookup 查询。这批药用于伴侣动物、马、异宠、动物园动物、野生动物和水生动物,不用于食用动物。

Wedgewood 表示,药效过低的风险是治疗无效,药效过高的风险是中毒或过量;截至公告时公司已收到98起投诉,其中7起严重,有健康担忧的客户应联系自己的兽医。公司已委托 Sedgwick 协调召回,通过电子邮件和信件通知受影响客户,并安排退款或在可能的情况下换货;动物主人可于周一至周五上午8时至晚9时、周六上午9时至下午5时(东部时间)拨打 866-562-5931。兽医诊所和药房应立即检查库存、隔离受影响产品,已经把产品配发出去的应识别并通知其客户。

公告称,此次召回是在 FDA 知情的情况下进行的;使用该产品出现的不良反应或质量问题可通过 1-888-FDA-VETS 或 FDA 网站向 FDA 报告。

Wedgewood Pharmacy Recalls Compounded Veterinary Medications Over Potency Issues: 98 Complaints, 7 Serious, FDA Notice Says

The U.S. Food and Drug Administration (FDA) posted a company recall announcement on October 21, 2026: Wedgewood Pharmacy LLC of Swedesboro, in Gloucester County, New Jersey, is recalling certain compounded veterinary medications within expiry at the provider and customer level because inconsistencies in the reliability of certain analytical testing data generated by its laboratory could result in subpotent or superpotent products. The affected products were shipped between February 18 and October 6, 2026, to veterinary practices, pharmacies and other customers nationwide. Animal owners who received affected product should stop use, retain the product and contact the recall service at 866-562-5931.

The company said the issue was discovered through its own quality processes. Dosage forms covered include powders, pastes, oral suspensions, injectables, ophthalmic ointments and solutions, ear solutions and suspensions, topical sprays and gels, and a complete list of affected products, lot numbers and expiration dates is available at wedgewood.com/recall-lookup. The products are intended for companion, equine, exotic, zoo, wildlife and aquatic animals, and are not intended for use in food-producing animals.

Wedgewood said the health risk of low potency is ineffective treatment, while high potency can lead to toxicity or overdose. To date the company has received 98 complaints, of which 7 are serious, and customers should contact their veterinarians with medical concerns. Wedgewood has engaged Sedgwick to coordinate the recall, notify affected customers by email and mail, and arrange refunds or, where possible, replacements; owners can call 866-562-5931 Monday through Friday 8 a.m. to 9 p.m. Eastern and Saturday 9 a.m. to 5 p.m. Eastern. Veterinary practices, pharmacies and other customers should immediately examine their inventory, quarantine affected product, and practices or pharmacies that further dispensed affected product should identify and notify their customers.

The announcement said the recall is being conducted with the knowledge of the FDA, and adverse reactions or quality problems may be reported to the FDA at 1-888-FDA-VETS or online through the FDA's animal adverse event reporting page.

来源:GSM·美国(原文链接)

图片来源:兽医诊所内的一只狗(资料图)。MarkBuckawicki 摄,CC0,经 Wikimedia Commons。 / A dog at a veterinary office (file photo). Photo by MarkBuckawicki, CC0, via Wikimedia Commons.

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