Why it was recalled
Lack of Assurance of Sterility
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: A2D08, Exp. Date Mar-24; A2F02, Exp. Date May-24; A2I03, Exp. Date Aug-24; A2L03, A2L04, Exp. Date Nov-24; A3C03, A3C05, Exp. Date Feb-25 A3H01, A3H03, Exp. Date Jul-25
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0352-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 30, 2024
- FDA report date
- Mar 6, 2024
- Quantity
- 355,633 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Brassica Pharma Pvt Ltd
Original FDA data
Every field from FDA enforcement report D-0352-2024, exactly as published.
Show all FDA fields
- City
- Thane
- Status
- Ongoing
- Country
- India
- Event ID
- 93885
- Address
- Plot No. T-68, T 68 (Pt), T-63, Midc
- Address (line 2)
- Tarapur, Boisar
- Code information
- Lot #: A2D08, Exp. Date Mar-24; A2F02, Exp. Date May-24; A2I03, Exp. Date Aug-24; A2L03, A2L04, Exp. Date Nov-24; A3C03, A3C05, Exp. Date Feb-25 A3H01, A3H03, Exp. Date Jul-25
- Report date
- Mar 6, 2024
- Product type
- Drugs
- Recall number
- D-0352-2024
- Classification
- Class II
- Recalling firm
- Brassica Pharma Pvt Ltd
- Product quantity
- 355,633 units
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Jan 30, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 28, 2024