Product Safety Recalls

Product Recall Tracker

NYSTATIN Recall D-0695-2022

Description: Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, NDC 52565-042-30; c) 60 grams tubes, NDC 52565-042-60, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

NYSTATIN Recall D-0695-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0695-2022
Event ID89798
BrandNYSTATIN AND TRIAMCINOLONE ACETONIDE
Generic NameNYSTATIN AND TRIAMCINOLONE ACETONIDE
ManufacturerNYSTATIN AND TRIAMCINOLONE ACETONIDE
Original Package?1
Active SubstanceNYSTATIN TRIAMCINOLONE ACETONIDE
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity217,184 tubes
Recall ReasoncGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Drug ClassificationClass II
Drug Code Info20220330
Product NDC52565-042
Product NUIN0000175498 M0017172 N0000175576
Pharma Class (EPC)Polyene Antifungal [EPC]
Pharma Class (CS)Polyenes [CS]
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Unique Ingredient IdentifierBDF1O1C72E F446C597KA
Drug Application NumberANDA208287
Structured Product Labeling (SPL ID)1090fb75-b1de-4939-8695-2870797e40bc
Structured Product Labeling (SPL Set ID)373276df-6a72-44cb-82a2-4098a16d86c7
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied.
Recall.report is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.