Class II · Moderate risk
Gs Anti Diarrheal Loperamide Caplet 12 Ct Sku 915632 Imodium Ad…
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
Cause type: Packaging defect
Failed child-resistant closures, leaks, cracked containers, or a defective delivery device. Packaging failures risk accidental exposure (especially to children) or product contamination. All packaging defect recalls.
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
Drug: Loperamide
- 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 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Loperamide recalls
See all
Class II · Moderate risk
Loperamide Hydrochloride capsules
cGMP deviations: Temperature abuse
Class III · Low risk
Loperamide HCL Tablets USP
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
Other recalls by Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
All 2012 recalls
Class II · Moderate risk
Concentrated Motrin
Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed
Other packaging defect recalls from 2012
All packaging defect recalls
Class III · Low risk
Flanax (aluminum hydroxide, magnesium hydroxide, and simethicone)
Defective Container: Product lacks tamper evident breakaway band on cap.
Class III · Low risk
EstroGel (estradiol gel)
Defective Container: Pump head detaching from the canister unit upon removal of the overcap.
Class II · Moderate risk
Nutropin AQ NuSpin 10
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
Class II · Moderate risk
Nutropin AQ NuSpin 20
Miscalibrated and/or Defective Delivery System: Genentech has received complaints for Nutropin AQ NuSpin 10 & 20 reporting that the dose knob spun slowly and the injection took longer than usual (slow dose delivery).
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