D-1152-2022 Class II Terminated
FDA drug recall D-1152-2022 was initiated by Mayne Pharma Inc on Jun 9, 2022 and is designated Class II. Reason for recall: Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint. The recall status is terminated (terminated Aug 23, 2023). Affected quantity: 1440 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 29, 2022
- Initiation Date
- Jun 9, 2022
- Termination Date
- Aug 23, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1440 cartons
Product Description
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.
Distribution Pattern
Nationwide in the US Market
Code Information
Lot: 41179A Exp. Jan 2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1152-2022
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026