Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Pe
Summary
The FDA issued a Class II for Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Per by Padagis US LLC. Reason: CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness..
Details
Source
Drug Recall
External ID
D-1497-2022
Action Date
2022-09-07
Status
Terminated
Category
drug
Product Description
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.
Lot/Code Info: Lot 2CT0486 , Exp 02/29/2024
Quantity Affected: 57,816 tubes
Reason for Recall
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2022-08-17
Company
Minneapolis, MN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 133 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Padagis US LLC has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Padagis US LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Padagis US LLC have FDA actions?
Padagis US LLC has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1497-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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