The FDA reported that India-based Brassica Pharma Pvt. Ltd. has voluntarily recalled four ophthalmic ointment products—distributed across the United States—due to a lack of sterility assurance.
Let’s get right to these products.
With expiration dates ranging from February 2024 to September 2025, these include:
- Equate Lubricant Eye Ointment (Walmart)
- Active Ingredients: Mineral Oil 42.5%, White Petrolatum 57.3%
- NDC: 79903-026-35
- Lot # A2E01 (Expiration date: Apr 2024)
- Lot # A2L05 (Expiration date: Nov 2024)
- Lot # A3B01 (Expiration date: Jan 2025)
- Lot # A3C01 (Expiration date: Feb 2025)
- Lot # A3H05 (Expiration date: Jul 2025)
- Equate Stye Lubricant Eye Ointment (Walmart)
- Active Ingredients: Mineral Oil 31.9%, White Petrolatum 57.7%
- NDC: 79903-028-35
- Lot # A2D08 (Expiration date: Mar 2024)
- Lot # A2F02 (Expiration date: May 2024)
- Lot # A2I03 (Expiration date: Aug 2024)
- Lot # A2L03 (Expiration date: Nov 2024)
- Lot # A2L04 (Expiration date: Nov 2024)
- Lot # A3C03 (Expiration date: Feb 2025)
- Lot # A3C05 (Expiration date: Feb 2025)
- Lot # A3H01(Expiration date: Jul 2025)
- Lot # A3H03 (Expiration date: Jul 2025)
- CVS Health Lubricant Eye Ointment (CVS Health)
- Active Ingredients: Mineral Oil 31.9%, White Petrolatum 57.7%
- NDC: 76168-707-35
- Lot # A2F03 (Expiration date: May 2024)
- Lot # A2I02 (Expiration date: Aug 2024)
- Lot # A2L02 (Expiration date: Nov 2024)
- Lot # A3C04 (Expiration date: Feb 2025)
- Lot # A3H04 (Expiration date: Jul 2025)
- Lubricant PM Ointment (AACE Pharmaceuticals)
- Active Ingredients: Mineral Oil 42.5%, White Petrolatum 57.3%
- NDC: 71406-124-35
- Lot #: A2G01 (Expiration date: Jun 2024)
- Lot #: A2G02 (Expiration date: Jun 2024)
- Lot # A3F08 (Expiration date: May 2025)
- Lot # A3F09 (Expiration date: May 2025)
- Lot # A3J17 (Expiration date: Sept 2025)
- Lot # A3J18 (Expiration date: Sept 2025)
And the risk?
Per Brassica in a February 12, 2024 statement, there’s the potential risk of eye infection or related harm.
The reason: ophthalmic drug products have an increased risk of harm to users due to their direct periorbital or ocular surface application, thereby potentially bypassing some of the body’s natural defenses.
Where are these sold?
Across the United States at wholesalers, retailers, and via product distributors, specifically Walmart, CVS, and AACE Pharmaceuticals.
Brassica is notifying each distributor, who will in turn “ be further notifying the wholesalers and retailers via mail of this voluntary recall and arranging for return of all impacted products listed above,” the company stated.
And how did this come to attention?
A lack of sterility assurance was noted at Brassica’s manufacturing facility during an FDA inspection, the company stated.
Quick refresher on this company, please.
Formed in 1994 and based in Thane, Maharashtra, India, Brassica is a contract development and manufacturing organization of 250+ formulations, including sterile semi-solids, dermatologicals, and liquid orals.
The manufacturer currently operates two facilities in India with the most recently commissioned 2017 facility established to provide manufacturing for the EU and other regulated markets (i.e. United States).
Any reports of related adverse reactions?
As of Feb. 16, 2024, Brassica noted that it has not received any reports of adverse events (AEs) associated with the use of their manufactured products.
However, consumers are advised to contact their eyecare practitioner (ECP) or healthcare provider (HCP) if they might experience any problems related to taking/using the products.
What should I do if I have one of the recalled products?
The company is asking for wholesalers, distributors, and retailers to cease distribution of the recalled products and for consumers to immediately discontinue use and return the products to their place of purchase.
Should I notify the FDA as well?
Yes—through the FDA's MedWatch Adverse Event Reporting program via 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
What if I have further questions?
Consumers with any related questions may contact Brassica Pharma Pvt. Ltd. at 1-833-225-9564 or info@brassicapharma.com.