Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834

FDA recall notice · announced June 29, 2022 · Mayne Pharma

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834

Reason for recall

Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.

Notes

Distribution: Nationwide in the US Market
Lot/code information: Lot: 41179A Exp. Jan 2023
Quantity: 1440 cartons
Status: Terminated
Products in this recall event:
- Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834 (D-1152-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.