Status
Ongoing
Drug Enforcement D-0351-2024
Lack of Assurance of Sterility
Classification
Class II
Report Date
March 6, 2024
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 315,842 units
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Brassica Pharma Pvt Ltd
- Address
-
Plot No. T-68, T 68 (Pt), T-63, Midc, Tarapur, Boisar
India - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0351-2024
- Event ID
- 93885
- Recall initiation date
- January 30, 2024
- Center classification date
- February 28, 2024
- Code info
- Lot #: A2E01, Exp. Date Apr-24; A2L05, Exp. Date Nov-24, A3B01, Exp. Date Jan-25; A3C01, Exp. Date Feb-25
- More code info
- —