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Recall Observatory FDA recall evidence

Drug product

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2

D-0075-2024

December 02, 2022

Class II

Product summary

Firm
GlaxoSmithKline Consumer Healthcare Holdings LLC
Event
Event 93255
Status
Completed
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-0075-2024

Official wording

Reason: Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

Code information: Lot #: HV6B, Exp. Date 9/30/2027

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    Foreign Substance