FDA recall D-1104-2023

Product

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

Reason for recall

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.

Distribution

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

Key facts

Status

Ongoing

Initiation date

2023-08-14

Report date

2023-08-30

Voluntary/Mandated

N/A

Location

Arlington, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1104-2023