September 2022 FDA Recall Triamcinolone Acetonide by Direct Rx
D-1535-2022 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Direct Rx on September 12, 2022 for the product Triamcinolone Acetonide. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Physicians and Medical Facilities in GA and ID and the recall is currently completed.
Recall Number: D-1535-2022
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
09-12-2022
09-21-2022
20 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.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Direct Rx
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.
Physicians and Medical Facilities in GA and ID
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.
Batch or Lot Expiration Information
Lot# Lot: 12JY2216, Exp. 2/29/24
