NBC NEWS – Four types of eye ointment were recalled on Feb. 26 due to concerns that they were manufactured in an unsanitary facility.
The products — Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment and AACE Pharmaceuticals’ Lubricant PM Ointment — were sold nationwide in some Walmart and CVS stores. They have expiration dates ranging from February 2024 to September 2025.
Brassica Pharma Pvt. Ltd., the manufacturer, said in a statement that the potential contamination could lead to eye infections, though no such issues had been reported as of Feb. 16.
The recall is separate from a cluster of bacterial infections linked to contaminated eyedrops, which led to the recall of two brands — EzriCare Artificial Tears and Delsam Pharma’s Artificial Tears — last year.
The FDA has also warned people not to use 28 additional eyedrop products after investigators found unsanitary conditions in a facility where the drops were manufactured …
Company Announcement
FOR IMMEDIATE RELEASE – 12 February, 2024 – Thane, Maharashtra, India, Brassica Pharma Pvt. Ltd. is voluntarily recalling Eye Ointment products listed in the table below with expiration date ranging from February 2024 to September 2025.
The products are being recalled due to lack of sterility assurance at the facility noted during an inspection conducted by the Food and Drug Administration (FDA).
Risk Statement: For those patients who use these products, there is a potential risk of eye infections or related harm. These products are intended to be sterile.
Ophthalmic drug products pose a potential heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. To date, Brassica Pharma Pvt. Ltd. has not received any reports of adverse events up to 16th February 2024 related to this recall.
These products were distributed nationwide to wholesalers, retailers, and via the product distributor, Walmart, CVS and AACE Pharmaceuticals Inc.
Brassica Pharma Pvt. Ltd. Is notifying its distributors AACE Pharmaceuticals Inc and its retailers Walmart and CVS. These distributors shall be further notifying the wholesalers and retailers via mail of this voluntary recall and arranging for return of all impacted products listed above.
Consumers, distributors and retailers that have any product which is being recalled should cease distribution of the product. Consumers should stop using the recalled Eye Ointment and may return any of the above listed products to the place of purchase.
Consumers with questions regarding this recall can contact Brassica Pharma Pvt. Ltd. at +1 833-225-9564 or [email protected]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online
Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
