BioLyte Laboratories is voluntarily recalling lots of their topical gel at risk of possible microbial contamination can result in increased infections that may require medical intervention and could be potentially life threatening to certain individuals.
Not sure what’s been recalled or withdrawn from the market? Catch up on the US Food and Drug Administration’s (FDA’s) recalls market withdrawals from this past week. For possible microbial contamination, BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel.
Some water contamination issues that potentially could have affected this product have been found in some of the active ingredients in this product.
While no reports of illness or injury have been reported to date, possible microbial contamination can result in increased infections that may require medical intervention and could be potentially life threatening to certain individuals.
For more information on this recall, check out the FDA’s statement. For potential lack of sterility assurance, Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician, or consumer level.
No reports of patient complaints or adverse events related to this recall have been reported to date. While there is no indication that these products are actually contaminated, the recall is being issued out of caution.
All compounded sterile drug products that were distributed nationwide within the last 12 months and are within expiry are included in the recall.
For more information on this recall, check out the FDA’s statement.For potential eye damage, Alcon’s CyPass Micro-Stent is being withdrawn from the market. Physicians are also being asked to cease implantation of the device immediately. The device was initially approved by the FDA in 2016 and was intended to reduce eye pressure in adults with open-angle glaucoma.
Following a post-approval study in treated patients through 5 years post-surgery, a concerning difference in the degree of corneal cell loss was demonstrated in patients administered the CyPass device compared to those who were not.
Almost 2 times less endothelial cell density was experienced in patients administered the CyPass device compared to those who did not (27% vs 10%).
For more information on this market withdrawal, check out the FDA’s statement.