August 2022 FDA Recall Triamcinolone Acetonide by Padagis Us Llc
D-1497-2022 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Padagis Us Llc on August 17, 2022 for the product Triamcinolone Acetonide. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1497-2022
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
08-17-2022
09-07-2022
57,816 tubes
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.
Padagis US LLC
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 USA
09-28-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36.
Batch or Lot Expiration Information
Lot# Lot 2CT0486 , Exp 02/29/2024
