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Recall Observatory FDA recall evidence

Drug product

TUMS a) Assorted, 12 Ct.; b) Extra Strength (EX) Assorted Berries, 12-count #1194A *05/27; c)Extra Strength (EX) Assorted Fruit, 12-count, #1194C *03/27

D-0279-2026

December 26, 2025

Class II

Product summary

Firm
GOLD STAR DISTRIBUTION INC
Event
Event 98239
Status
Ongoing
Classification
Class II
Quantity
Unavailable
Official record key
drug-enforcement:D-0279-2026

Official wording

Reason: CGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.

Code information: All lots within expiry distributed by Gold Star Distribution.

Distribution pattern: US Nationwide.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations