Mayne Pharma recalls Clonidine Transdermal System 0.3 mg/day patches due to defective delivery system that may not release properly after 3 months.
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Mayne Pharma is recalling Clonidine Transdermal System patches because the delivery system may not release properly after 3 months. This could lead to incorrect medication levels if the patches fail to deliver the drug as intended.
The delivery system may not release the medication properly after 3 months due to a defect in the release liner removal force. This could cause inconsistent drug delivery if the patches fail to function as intended.
People with prescriptions for Clonidine Transdermal System 0.3 mg/day patches (NDC 51862-455-01) per carton (51862-455-04) manufactured in Greenville, NC. Those with the specific lot number 41179A (expiring Jan 2023) are most at risk.
Check for Clonidine Transdermal System 0.3 mg/day patches (NDC 51862-455-01) per carton (51862-455-04) with lot number 41179A, expiring January 2023, manufactured in Greenville, NC.
Verify the product's lot number and expiration date to confirm if it matches the recalled items.
The recall indicates a potential issue with the delivery system after 3 months, but the product is safe for use until the defect becomes a problem.
The recall does not specify a remedy, so check the product details to see if it matches the recalled items.
The recall record does not mention a replacement or remedy process.
We’ve drafted a message you can send Mayne Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-1152-2022 — Mayne Pharma Mayne Pharma Hello, I own a Mayne Pharma that is covered by recall D-1152-2022 from Mayne Pharma. 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.
