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Recall Observatory FDA recall evidence

Drug 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

D-0352-2024

January 30, 2024

Class II

Product summary

Firm
Brassica Pharma Pvt Ltd
Event
Event 93885
Status
Ongoing
Classification
Class II
Quantity
355,633 units
Official record key
drug-enforcement:D-0352-2024

Official wording

Reason: Lack of Assurance of Sterility

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

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility