Class II · Moderate risk
Certain Over-The-Counter
CGMP Deviations: OTC products were stored outside of labeled temperature requirements.
All Over-The-Counter
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by Inmar.
- Recalling firm
- Inmar Supply Chain Solutions, LLC
- Origin
- TX, United States
- Initiated by
- N/A
- FDA recall number
- D-1104-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other temperature excursion recalls from 2023
All temperature excursion recalls
Class II · Moderate risk
Doxil (doxorubicin hydrochloride liposome injection)
CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions during transportation were released by mistake.
Class II · Moderate risk
Advil Liqui-Gels Solubilized Ibuprofen Capsules
CGMP deviation: product outside labeled storage temperature requirements.
Class II · Moderate risk
Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen
CGMP deviation: product outside labeled storage temperature requirements.
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