Multi event Drug Recall Enforcement Report Class II voluntary initiated by Brassica Pharma Pvt Ltd, originally initiated on 01-30-2024 for the product Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304 The product was recalled due to lack of assurance of sterility. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
D-0352-2024 | 01-30-2024 | 03-06-2024 | Class II | 355,633 units | Equate Stye Lubricant Eye Ointment (Mineral Oil 31.9%, White Petrolatum 57.7%), Packaged in 3.5 g tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-028-35, UPC 681131395304 | Lack of Assurance of Sterility | Ongoing |
D-0354-2024 | 01-30-2024 | 03-06-2024 | Class II | 355,120 units | Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356 | Lack of Assurance of Sterility | Ongoing |
D-0351-2024 | 01-30-2024 | 03-06-2024 | Class II | 315,842 units | Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298 | Lack of Assurance of Sterility | Ongoing |
D-0353-2024 | 01-30-2024 | 03-06-2024 | Class II | 159,334 units | CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, UPC 050428634141 | Lack of Assurance of Sterility | Ongoing |
Recalled Products
NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
71406-124 | Lubricant Pm | Mineral Oil, White Petrolatum Lubricant Eye Ointment | Ointment | Ophthalmic | Aace Pharmaceuticals, Inc. | Human Otc Drug |