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Recall Observatory FDA recall evidence

Drug product

Equate Support Advanced Lubricating Eye Drops, Preservative Free, Sterile, 25 Single-Use Containers, 0.02 Fl. oz. (0.6 mL), W-M item #: 563031654, Distributed by: Walmart Inc., Bentonville, AR 72716, NDC 49035-882-54

D-0370-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
99420 units
Official record key
drug-enforcement:D-0370-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lot #: RKP 11/19 RIN 09/19 SLC 12/20 RIF 09/19 TBE 02/21 TBI 02/21 SHB 08/20

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility