FDA Announces Voluntary Recall of Eye Ointments Due to Sterility Concerns

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Brassica Pharma Pvt. Ltd. is voluntarily recalling eye ointment products with expiration dates from February 2024 to September 2025.

FDA logo | Image Credit: US Food and Drug Administration

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has announced a voluntary recall of eye ointment products after an inspection identified a lack of sterility assurance at the manufacturing facility.1

Announced by the FDA on February 26, 2024, the nationwide recall was issued by Brassica Pharma Pvt. Ltd. and centered around eye ointment products sold at leading retailers, including CVS and Walmart.

The expiration dates of the products range from February 2024 to September 2025. Intended to be sterile, ophthalmic drug products present a potentially increased risk of harm for users, as drugs applied to the eye pass bypass many 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,” wrote the agency in the recall alert.

These ophthalmic products were distributed to wholesalers, retailers, and via the product distributor, Walmart, CVS, and AACE Pharmaceuticals, Inc. Brassica Pharma Pvt. Ltd. has informed its distributor AACE Pharmaceuticals, Inc. and both of the identified retailers of the voluntary recall.

The company intends to notify the wholesalers and retailers via mail and arrange for the return of all impacted products. For all information related to the recalled ophthalmic products, view the below list:

Brand Name: AACE Pharmaceuticals

  • Lubricant PM Ointment
    • A2G01Jun-24
    • A2G02Jun-24
    • A3F08May-25
    • A3F09May-25
    • A3J17Sep-25
    • A3J18Sep-25

Brand Name: Equate

  • Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%, Lanolin Alcohols)
    • A2E01Apr-24
    • A2L05Nov-24
    • A3B01Jan-25
    • A3C01Feb-25
    • A3H05Jul-25
  • Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid, Wheat Germ Oil)
    • A2D08Mar-24
    • A2F02May-24
    • A2I03Aug-24
    • A2L03Nov-24
    • A2L04Nov-24
    • A3C03Feb-25
    • A3C05Feb-25
    • A3H01Jul-25
    • A3H03Jul-25

Brand Name: CVS Health

  • CVS Health Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%, Microcrystalline Wax, Stearic Acid Wheat Germ Oil
    • A2F03May-24
    • A2I02Aug-24
    • A2L02Nov-24
    • A3C04Feb-25
    • A3H04Jul-25

The FDA urged consumers, distributors, and retailers with any recalled eye ointment to immediately cease distribution and use of the product. Consumers were urged to contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using the drug product.

Healthcare professionals should report any adverse events or quality problems with any medicine to the FDA’s MedWatch Adverse Event Reporting program.2

References

  1. Affairs O of R. Brassica pharma pvt. ltd.. issues voluntary nationwide recall of Equate Lubricant Eye Ointment, equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment, lubricant PM ointment due to potential lack of sterility. U.S. Food and Drug Administration. February 26, 2024. Accessed February 27, 2024. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/brassica-pharma-pvt-ltd-issues-voluntary-nationwide-recall-equate-lubricant-eye-ointment-equate-stye.
  2. Commissioner O of the. Reporting serious problems to FDA. U.S. Food and Drug Administration. Accessed February 27, 2024. https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda.
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