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Recall Observatory FDA recall evidence

Drug product

Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Manufactured by: Nomax, Inc, St. Louis, MO 63123, NDC: 51801-008-15

D-0387-2021

April 13, 2021

Class III

Product summary

Firm
Nomax Inc
Event
Event 87695
Status
Terminated
Classification
Class III
Quantity
78 cartons
Official record key
drug-enforcement:D-0387-2021

Official wording

Reason: Subpotent Drug

Code information: LOT 13336 EXP 07/23

Distribution pattern: Nationwide USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent