Drug 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
D-1152-2022
Product summary
- Firm
- Mayne Pharma Inc
- Event
- Event 90406
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1440 cartons
- Official record key
drug-enforcement:D-1152-2022
Official wording
Reason: Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
Code information: Lot: 41179A Exp. Jan 2023
Distribution pattern: Nationwide in the US Market
Derived failure modes
-
Potency or specification failure
Out of specification