Class II · Moderate risk Terminated
Loperamide Hydrochloride capsules, USP, 2 mg, 100-count bottle, Rx only, MFG: Mylan Pharma, NDC 0378-2100-01
Reason cGMP deviations: Temperature abuse
Gs Anti Diarrheal Loperamide Caplet 12 Ct Sku 915632 Imodium Ad Mint 4 Oz Sku 902080…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: product held outside appropriate storage temperature conditions.
What was recalled
GS ANTI DIARRHEAL LOPERAMIDE CAPLET 12 CT SKU 915632 IMODIUM AD MINT 4 OZ SKU 902080 IMODIUM AD CAPLET 6 CT SKU 915628 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
- Recalling firm
- Family Dollar Stores, Llc.
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1449-2022
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 III · Low risk Terminated
LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio…
Reason Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton…
Class III · Low risk Terminated
Imodium Multi-Symptom Relief Caplets, Loperamide HCl 2 mg/Simethicone 125 mg, 18 count blister pack cartons, McNeil Consumer…
Reason Defective Container; damaged blister units
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