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Recall Observatory FDA recall evidence

Drug product

ActivEyes Sterile Altalube Ointment, Net Wt 1/8 oz (3.5g), NDC 59390-198-50

D-0418-2020

July 02, 2019

Class II

Product summary

Firm
Altaire Pharmaceuticals, Inc.
Event
Event 83265
Status
Completed
Classification
Class II
Quantity
161077 units
Official record key
drug-enforcement:D-0418-2020

Official wording

Reason: Lack of Assurance of Sterility

Code information: RJH 10/20 1/10/2018 RLL 12/20 8/22/2018 SGH 07/21 8/23/2018 SIF 09/21 10/16/2018 SKC 11/21 12/12/2018 TCG 03/22

Distribution pattern: U.S.A. Nationwide

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility