FDA Recall D-1104-2023

Inmar Supply Chain Solutions, LLC · Arlington, TX

Class II Ongoing 1004 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Miscellaneous

Quantity: Unknown

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.

Recall record

Recall number: D-1104-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: N/A
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Separate Distribution List (salvage buyers) provided by Inmar and will be uploaded. Final customer distribution unknown.
Recall initiated: 2023-08-14
Classified by FDA Center: 2023-08-24
FDA published: 2023-08-30
Recalling firm: Inmar Supply Chain Solutions, LLC
Firm location: Arlington, TX

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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