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Recall Observatory FDA recall evidence

Drug product

Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3

D-0096-2022

October 05, 2021

Class III

Product summary

Firm
A-S Medication Solutions LLC.
Event
Event 88853
Status
Terminated
Classification
Class III
Quantity
72 bottles
Official record key
drug-enforcement:D-0096-2022

Official wording

Reason: Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.

Code information: Lot #: 1256330

Distribution pattern: FL, IN, MN, WI

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.