The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1404-2012·Announced 2012-07-11

Imodium Multi-Symptom Relief Caplets Recalled for Defective Containers

McNeil Consumer Healthcare is recalling Imodium Multi-Symptom Relief Caplets due to defective containers and damaged blister units.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for packaging-only problems.

Plain-English summary

McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., is recalling Imodium Multi-Symptom Relief Caplets (Loperamide HCl 2 mg/Simethicone 125 mg) in 18-count blister pack cartons. The recall involves 53,892 packages distributed nationwide. The specific lot number is CMF023 with an expiration date of 07/13.

The recall was initiated because of defective containers and damaged blister units. The U.S. Food and Drug Administration has classified this as a Class III recall, indicating that the defect is unlikely to cause adverse health consequences.

Consumers with this product should stop using it and contact the manufacturer for instructions on how to return the product or obtain a refund.

The recalled product

Product
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
Affected units
53,892

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 (2)

  • Lot #CMF023
  • Expiration 07/13.

Distribution

Distributed nationwide across the United States.

Same manufacturer · Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.

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