Recalls / Class II
Class IID-1152-2022
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
- Brand name
- Clonidine
- Generic name
- Clonidine
- Active ingredient
- Clonidine
- Route
- Transdermal
- NDCs
- 51862-455, 51862-453, 51862-454
- FDA application
- ANDA079090
- Affected lot / code info
- Lot: 41179A Exp. Jan 2023
Why it was recalled
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Recalling firm
- Firm
- Mayne Pharma Inc
- Manufacturer
- Mayne Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1240 Sugg Pkwy, Greenville, North Carolina 27834-9006
Distribution
- Quantity
- 1440 cartons
- Distribution pattern
- Nationwide in the US Market
Timeline
- Recall initiated
- 2022-06-09
- FDA classified
- 2022-06-21
- Posted by FDA
- 2022-06-29
- Terminated
- 2023-08-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1152-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.