Class II · Moderate risk Ongoing
Gs Anti Diarrheal Loperamide Caplet 12 Ct Sku 915632 Imodium Ad…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Imodium Multi-Symptom Relief Caplets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Defective Container; damaged blister units
What was recalled
Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer Healthcare, Div of McNeil-PPC Inc., Fort Washington, PA
- Recalling firm
- Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1404-2012
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Loperamide recalls
See all
Class II · Moderate risk Terminated
Loperamide Hydrochloride capsules
Reason cGMP deviations: Temperature abuse
Class III · Low risk Terminated
Loperamide HCL Tablets USP
Reason Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
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