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Recall Observatory FDA recall evidence

Drug product

Equate Restore PM Nighttime Lubricant Eye Ointment, Sterile, Net Wt. 0.125 oz. (3.5g), Distributed by: Walmart Stores Inc., Bentonville, AR 72716, W-M item #551282425, NDC 49035-191-50

D-0367-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
1537130 units
Official record key
drug-enforcement:D-0367-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: SKG,Exp 08/21; SHK, Exp 08/21; SHJ, Exp 08/21; SEC, Exp 05/21; SCB, Exp 03/21; SBC, Exp 02/21; RLB, Exp 12/20; RBB, Exp 02/20; RHR, Exp 08/20; RFK, Exp 06/20; RAB, Exp 01/20; TAD, Exp 01/22; TAQ, Exp 01/22; TBI, Exp 02/22; TDB, Exp 04/22; QHE, Exp 08/19; QJD, Exp 10/19; SGE, Exp 07/21

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility