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Recall Observatory FDA recall evidence

Drug product

Equate Support Advanced Lubricant Gel Drops Multi Dose Preservative Free, 7.5 mL, NDC 49035-882-52

D-0475-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0475-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: 19015 01/21 19117 04/21 18080 07/20 18111 05/20

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility