The Recall Desk
ModerateFDA (Drugs)·D-1152-2022·Announced 2022-06-29

FDA Recalls Clonidine Transdermal Patches for Delivery System Defect

Mayne Pharma is recalling 1,440 cartons of Clonidine transdermal patches nationwide due to an out-of-specification defect in the release liner that could affect proper drug delivery.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The defect was identified through routine stability testing and represents a precautionary recall for a manufacturing specification failure in the transdermal delivery system.

Plain-English summary

Mayne Pharma Inc is recalling 1,440 cartons of Clonidine (Clonidine) 0.3 mg/day transdermal patches nationwide. The patches are subject to recall due to a defect in the transdermal delivery system identified during stability testing: the release liner removal force fails to meet manufacturing specifications at the 3-month stability timepoint.

Clonidine is a prescription medication used to treat high blood pressure and ADHD. When the release liner does not perform to specification, there is a potential risk that the patch may not deliver the medication correctly or consistently to patients.

The affected product is Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches per Carton (NDC 51862-455-01 and 51862-455-04), Lot 41179A with an expiration date of January 2023.

Patients currently using patches from the affected lot should contact their pharmacist or healthcare provider. Do not stop taking Clonidine without medical guidance, as abrupt discontinuation can cause serious blood pressure changes. Patients should speak with their healthcare provider about replacement medication or alternative batches.

The recalled product

Product
CLONIDINE (CLONIDINE)
Brand
CLONIDINE
Manufacturer
Mayne Pharma Inc
Category
Drug — Transdermal Patch
Hazard
  • delivery-system-defect
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot: 41179A Exp. Jan 2023

Distribution

Distributed nationwide across the United States.

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