Mckesson Medical-Surgical recalls diphenhydramine oral solution due to temperature abuse risks. Products may have been shipped without proper temperature control, potentially causing safety issues.
cGMP deviations: Temperature abuse
Mckesson Medical-Surgical is recalling diphenhydramine HCl oral solution (25 mg/10 mL) because of temperature abuse risks. This could lead to unsafe conditions if the product is exposed to improper temperatures during storage or transport.
The recall is due to cGMP deviations related to temperature abuse. This means the product may have been stored or transported at temperatures that could compromise its safety, potentially leading to unsafe conditions.
Prescription holders of the recalled diphenhydramine oral solution are affected. Those who have the product and are unsure about its temperature history are at higher risk.
Check for the product name 'Diphenhydramine HCl oral solution, USP, 25 mg/10 mL' in 10 mL unit dose cups (NDC 0121-0978-10) or 100-count boxes (NDC 0121-0978-00). The product is prescription-only and manufactured by Pharmaceutical Associates Inc.
Identify the product by checking the NDC codes: 0121-0978-10 for unit dose cups or 0121-0978-00 for 100-count boxes.
The product was recalled due to cGMP deviations related to temperature abuse, meaning it may have been stored or transported at unsafe temperatures.
The recall notice does not specify a remedy, so you should check with your pharmacist or healthcare provider for guidance.
The recall indicates potential temperature abuse risks, but the official notice does not confirm if the product is unsafe to use.
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-1101-2022 — Mckesson Medical-Surgical Mckesson Medical-Surgical Hello, I own a Mckesson Medical-Surgical that is covered by recall D-1101-2022 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.
