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Recall Observatory FDA recall evidence

Drug product

Equate Sterile Lubricant Stye Ointment, Net wt. 0.125 oz. (3.5g), Distributed by: Wal-Mart Stores Inc., Bentonville, AR 72716, NDC 49035-875-50

D-0365-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
441792 units
Official record key
drug-enforcement:D-0365-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: SAJ, Exp 01/21; SFE, Exp 06/21; SIA, Exp 09/21; RIE, Exp 09/20; REH, Exp 05/20; RAD, Exp 01/20; TAH, Exp 01/22; TDD, Exp 04/22

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility