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Recall Observatory FDA recall evidence

Drug product

Nano Tears MXP Forte Clear Emollient Lubricant Gel Drops Twin Pack, Product Size: 2 x 10 mL, NDC 59390-144-51

D-0472-2020

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-0472-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: 17367 12/19 18174 7/20

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility