Search
Close this search box.

FDA Alert: Brassica Pharma Pvt. Ltd. Issues Voluntary Nationwide Recall of Eye Ointment Products Due to Potential Lack of Sterility

February 22, 2024

Audience: Pharmacy, Consumer

22 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.

Product Name

Package Description

Brand Name

NDC

Lot#
Exp Date

Exp
Date

Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%, Lanolin Alcohols) 3.5 gram tube, packaged in cardboard box with UPC Code 681131395298 Equate 79903-026-35 A2E01 Apr-24
A2L05 Nov-24
A3B01 Jan-25
A3C01 Feb-25
A3H05 Jul-25
Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid, Wheat Germ Oil) 3.5 gram tube, packaged in cardboard box with UPC Code 681131395304 Equate 79903-
028-35
A2D08 Mar-24
A2F02 May-24
A2I03 Aug-24
A2L03 Nov-24
A2L04 Nov-24
A3C03 Feb-25
A3C05 Feb-25
A3H01 Jul-25
A3H03 Jul-25
CVS Health Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid Wheat Germ Oil 3.5 gram tube, packaged in cardboard box with UPC Code 050428634141 CVS Health 76168-
707-35
A2F03 May-24
A2I02 Aug-24
A2L02 Nov-24
A3C04 Feb-25
A3H04 Jul-25
Lubricant PM Ointment 3.5 gram tube, packaged in cardboard box with UPC Code 371406124356 AACE Pharmaceuticals 71406-
124-35
A2G01 Jun-24
A2G02 Jun-24
A3F08 May-25
A3F09 May-25
A3J17 Sep-25
A3J18 Sep-25

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 info@brassicapharma.com. 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.

Source: FDA

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.