Mayne Pharma Inc recall records

1 reported ongoing

2 records in this archive. Latest source date Jun 9, 2022.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA drug enforcement

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

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

Class IIReported terminated

Distribution: Nationwide in the US Market

Official source for Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-...

Reasons in these listed records

  • Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
  • CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.

These examples come from this result page and are not a ranking of every recall reason.

Checking Mayne Pharma Inc

Is there a recall on mayne pharma inc right now?

This archive contains 2 records, including 1 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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