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Recall Observatory FDA recall evidence

Drug product

Carmex a) jar, 12 count, UPC: 083078123154, 083078113155; b) Tube, PEG, 12 count, UPC: 083078123147, 083078113148

D-0282-2026

December 26, 2025

Class II

Product summary

Firm
GOLD STAR DISTRIBUTION INC
Event
Event 98239
Status
Ongoing
Classification
Class II
Quantity
Unknown
Official record key
drug-enforcement:D-0282-2026

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