All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
Summary
The FDA issued a Class II for All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar by Inmar Supply Chain Solutions, LLC. Reason: CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Also, due to unusually hot weather, FDA Recalled Produc.
Details
Source
Drug Recall
External ID
D-1104-2023
Action Date
2023-08-30
Status
Ongoing
Category
drug
Product Description
All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
Lot/Code Info: Miscellaneous
Quantity Affected: 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.
Distribution
Separate Distribution List (salvage buyers) provided by Inmar and will be uploaded. Final customer distribution unknown.
Type: N/A
Recall Initiated: 2023-08-14
Company
Arlington, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 51 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Inmar Supply Chain Solutions, LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Inmar Supply Chain Solutions, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Inmar Supply Chain Solutions, LLC have FDA actions?
Inmar Supply Chain Solutions, LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1104-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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