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Recall Observatory FDA recall evidence

Drug product

TRP Pink Eye Relief, 10 mL, NDC 17312-013-15

D-0471-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
1,381,638 units
Official record key
drug-enforcement:D-0471-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: 17185 6/20 17228 7/20 17349 11/20 18073 3/21 18218 8/21 18303 12/21

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility

Field note

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