Home / Recalls / Mayne Pharma Inc / D-1152-2022

D-1152-2022 Class II Terminated

Recalled by Mayne Pharma Inc — Greenville, NC

Recall Details

Product Type
Drugs
Report Date
June 29, 2022
Initiation Date
June 9, 2022
Termination Date
August 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

Other recalls by Mayne Pharma Inc

  • D-0387-2022 Class II — Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, D (January 14, 2022)
  • D-0998-2020 Class II — Carbidopa and Levodopa Tablets, USP 25 mg/250mg, 100 ct bottle, Rx Only, Mayne P (March 2, 2020)
  • D-1129-2018 Class III — Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Onl (August 21, 2018)
  • D-0616-2018 Class III — Fabior (tazarotene) Foam, 0.1%, 100 grams can, Rx only, Distributed by: Mayne Ph (March 21, 2018)
  • D-0098-2018 Class II — Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distribute (November 9, 2017)