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Recall Observatory FDA recall evidence

Drug product

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

D-0351-2024

January 30, 2024

Class II

Product summary

Firm
Brassica Pharma Pvt Ltd
Event
Event 93885
Status
Ongoing
Classification
Class II
Quantity
315,842 units
Official record key
drug-enforcement:D-0351-2024

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: A2E01, Exp. Date Apr-24; A2L05, Exp. Date Nov-24, A3B01, Exp. Date Jan-25; A3C01, Exp. Date Feb-25

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility