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Recall Observatory FDA recall evidence

Drug product

GloStrips, Fluorescein Sodium Ophthalmic Strips USP (1.0 mg Fluorescein), Rx Only, 100 Sterile Strips per carton, Nomax, Inc., St. Louis, MO 63123, NDC 51801-009-40.

D-0463-2024

April 19, 2024

Class II

Product summary

Firm
Nomax Inc
Event
Event 94461
Status
Ongoing
Classification
Class II
Quantity
6,960 cartons
Official record key
drug-enforcement:D-0463-2024

Official wording

Reason: Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.

Code information: Lot #: 14708, Exp. 04/30/2024.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications