August 2023 FDA Recall Drug by Inmar Supply Chain Solutions, Llc
D-1104-2023 - CGMP Deviations

This Class II drug recall was initiated by Inmar Supply Chain Solutions, Llc on August 14, 2023 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Separate Distribution List (salvage buyers) provided by Inmar and will be uploaded. Final customer distribution unknown. and the recall is currently ongoing.

Recall Number: D-1104-2023

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.
Initiated
08-14-2023
Reported
08-30-2023
Quantity
Unknown

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92884
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Inmar Supply Chain Solutions, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
N/A
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Separate Distribution List (salvage buyers) provided by Inmar and will be uploaded. Final customer distribution unknown.
Product Description About Product Description
Full technical description of the product.
All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.

Batch or Lot Expiration Information

Lot# Miscellaneous