June 2022 FDA Recall Clonidine by Mayne Pharma Inc
D-1152-2022 - Defective Delivery System
This Class II drug recall was voluntarily initiated by Mayne Pharma Inc on June 9, 2022 for the product Clonidine. The FDA reported the reason for recall as defective delivery system. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1152-2022
Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
06-09-2022
06-29-2022
1440 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mayne Pharma Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the US Market
08-23-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot: 41179A Exp. Jan 2023
