Brassica Pharma recalls multiple lots of four eye ointments

Excerpt

The US FDA has published a company announcement from Brassica Pharma, India, announcing the voluntary recall of: five lots of Equate Lubricant Eye Ointment with expiry dates ranging from April 2024 to July 2025; nine lots of Equate Style Lubricant Eye Ointment with expiry dates ranging from March 2024 to July 2025; five lots of CVS Health Lubricant Eye Ointment with expiry dates ranging from May 2024 to July 2025; and six lots of AACE Pharmaceuticals Lubricant PM Ointment with expiry dates ranging from June 2024 to September 2025.The products, which are intended to be sterile, are being recalled due to lack of sterility assurance at the manufacturing facility, which was identified during an inspection conducted by the FDA.Patients who use the recalled products are at potential risk of eye infections or related harm. However, as of 16th February 2024, Brassica Pharma has not received any reports of adverse events related to this recall.These products were distributed nationwide in the US to wholesalers, retailers, and via the product distributors (Walmart, CVS and AACE Pharmaceuticals). Brassica Pharma is notifying its distributors and they will be notifying the wholesalers and retailers of this recall and arranging for return of all impacted products.Consumers should stop using the recalled eye ointments and return them to the place of purchase.Any adverse reactions experienced with the use of these products should be reported to the FDA MedWatch Adverse Event Reporting program. …