Mckesson Medical-Surgical recalls 2mg Loperamide capsules (NDC 0378-2100-01) due to temperature abuse risks. The recall affects prescription-only products from Mylan Pharma with specific lot numbers unidentifiable by the manufacturer.
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical has recalled prescription 2mg Loperamide Hydrochloride capsules (100-count) from Mylan Pharma due to temperature abuse risks. This could lead to unsafe drug conditions if the product is exposed to improper temperatures.
The product was manufactured under cGMP deviations related to temperature abuse. This means the capsules could become unsafe if stored or handled at temperatures outside the recommended range, potentially affecting their effectiveness or safety.
Prescription holders of the 2mg Loperamide capsules (NDC 0378-2100-01) from Mylan Pharma. Patients using these capsules for medical purposes are most at risk if the product was exposed to incorrect temperatures.
Check for the product name 'Loperamide Hydrochloride capsules, USP, 2 mg, 100-count bottle' with NDC code 0378-2100-01. The product is prescription-only and distributed by Mylan Pharma.
Identify the NDC code 0378-2100-01 on the product label to confirm it is part of the recall.
The product was manufactured under cGMP deviations related to temperature abuse, which could lead to unsafe conditions if exposed to improper temperatures.
Look for the product name 'Loperamide Hydrochloride capsules, USP, 2 mg, 100-count bottle' with NDC code 0378-2100-01. The product is prescription-only and distributed by Mylan Pharma.
The recall does not specify a remedy, so the manufacturer advises checking product details to confirm if it is affected.
We’ve drafted a message you can send Mckesson Medical-Surgical to request your refund or repair — edit it as you like.
Subject: Recall D-1092-2022 — Mckesson Medical-Surgical Mckesson Medical-Surgical Hello, I own a Mckesson Medical-Surgical that is covered by recall D-1092-2022 from Mckesson Medical-Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
