OTC Drug Products Recalled for Rodent Contamination and Storage Violations
Inmar Supply Chain Solutions is recalling all OTC drug products due to potential rodent exposure in its distribution center and temperature excursions during storage that may have compromised product integrity.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for potential rodent contamination and improper storage conditions at a distribution facility. No illnesses or injuries have been reported. Unconfirmed high-risk contamination hazards without reported illness are classified as High severity per the rubric.
Plain-English summary
Inmar Supply Chain Solutions, LLC is recalling all over-the-counter (OTC) drug products that it warehoused, salvaged, and sold. The FDA has classified this as a Class II recall due to current Good Manufacturing Practice (CGMP) deviations discovered at Inmar's distribution center.
The recall was initiated because of two CGMP violations: potential exposure to rodents and rodent activity observed in the distribution center, and exposure of products to temperatures exceeding the storage condition instructions on product labeling. The temperature excursions resulted from unusually hot weather conditions.
The affected products include all OTC drug products warehoused and sold by Inmar. A separate distribution list of salvage buyers has been provided to the FDA, though the final customer distribution is not fully known.
Consumers who have obtained OTC medications through Inmar's salvage operations should verify product storage conditions and appearance before use. For information about specific recalled products, contact Inmar or the FDA.
The recalled product
- Product
- All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
- Manufacturer
- Inmar Supply Chain Solutions, LLC
- Category
- Drug — Over-The-Counter
- Hazard
- rodent-contamination
- improper-storage
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Miscellaneous
Distribution
Distribution scope not specified by the agency.
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