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Recall Observatory FDA recall evidence

Drug product

All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.

D-1104-2023

August 14, 2023

Class II

Product summary

Firm
Inmar Supply Chain Solutions, LLC
Event
Event 92884
Status
Ongoing
Classification
Class II
Quantity
Unknown
Official record key
drug-enforcement:D-1104-2023

Official wording

Reason: CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Products may have been subjected to temperatures in excess of storage condition instructions on product labeling.

Code information: Miscellaneous

Distribution pattern: Separate Distribution List (salvage buyers) provided by Inmar and will be uploaded. Final customer distribution unknown.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations