Triamcinolone Acetonide Cream
FDA Recall NDC 0168-0002
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Triamcinolone Acetonide (NDC 0168-0002). A significant event, classified as Class II, was initiated on Apr 13, 2022 by E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc. The reported reason for this action was: "cGMP deviations: Temperature abuse"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
cGMP deviations: Temperature abuse
Apr 13, 2022
Jun 15, 2022
30 tubes
Recall Profile & Regulatory Data
Event ID
89646
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Nov 30, 2023
Product Description
Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0004-15
Batch or Lot Expiration Information
Lot# McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.
Affected Packages Involved in this Recall
0168-0003-15Product
0168-0003-80Product
0168-0004-15Product
0168-0004-80Product
0168-0004-16Product
0168-0002-15Product
Class III Terminated
Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%.
Jan 29, 2014
Mar 19, 2014
493,192 tubes
Recall Profile & Regulatory Data
Event ID
67329
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Fougera Pharmaceuticals Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
Dec 08, 2015
Product Description
Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8.
Batch or Lot Expiration Information
Lot# : 485P, 486P, 487P, 488P, Exp 06/15; 638P, 639P, 640P, Exp 07/15; 753P, 754P, 755P, Exp 08/15; 898P, 756P, 757P, 758P, 899P, 900P, 901P, 902P, Exp 09/15
Affected Packages Involved in this Recall
0168-0003-15Product
0168-0003-80Product
0168-0004-15Product
0168-0004-80Product
0168-0004-16Product
0168-0002-15Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
