FDA announces recall of two more eye drop brands
Two more brands of eye drops are being recalled after contamination risks that could result in blindness in one.
The Food and Drug Administration (FDA) has announced Pharmedica USA is voluntarily recalling two lots of Purely Soothing 15% MSM Drops due to non-sterility. Use of the contaminated eye drops could result in eye infections that could lead to blindness, the FDA said.
The recall is the second to come in recent months for eye drops. Earlier this year, Global Pharma Healthcare voluntarily recalled all lots within expiry of their Artificial Tears Lubricant Eye Drops due to possible contamination. The FDA announced the recall after the drops were linked to 55 reports of adverse events, including eye infections, permanent loss of vision and one death with a bloodstream infection.
The product, which was distributed online and at trade shows, is known under the brand name Purely Soothing and is used as an anti-inflammatory to assist with eye irritation and/or swelling.
Of note, Pharmedica said it has not received any reports of adverse events or illness related to the eye drops. The company advised consumers to stop using the product immediately and return it to the place of purchase. In addition, wholesalers and retailers should stop selling the product and return it to Pharmedica immediately or confirm it has been disposed of properly.
The FDA also announced the recall of six lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% from Apotex. The product is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension, according to the FDA.
The lots were recalled due to the possibility of broken caps, which could impact sterility. Cracks have developed in some of the caps of the solution bottles. The lots were distributed nationwide between April 05, 2022, and February 22, 2023.
Apotex is notifying all impacted accounts of the voluntary recall via email and mail and is arranging for return of all the product. Patients are asked to contact their pharmacy if they have received the identified lots or have questions regarding this recall.
Amy joined TriMed Media as a Senior Writer for HealthExec after covering home care for three years. When not writing about all things healthcare, she fulfills her lifelong dream of becoming a pirate by sailing in regattas and enjoying rum. Fun fact: she sailed 333 miles across Lake Michigan in the Chicago Yacht Club "Race to Mackinac."