Product Safety Recalls

Product Recall Tracker

HYDROCORTISONE BUTYRATE Recall D-0692-2022

Description: Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottles, NDC 52565-087-04, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

HYDROCORTISONE BUTYRATE Recall D-0692-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0692-2022
Event ID89798
BrandHYDROCORTISONE BUTYRATE
Generic NameHYDROCORTISONE BUTYRATE
ManufacturerHYDROCORTISONE BUTYRATE
Original Package?1
Active SubstanceHYDROCORTISONE BUTYRATE
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity30,497 bottles
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 NDC52565-087
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Unique Ingredient Identifier05RMF7YPWN
Drug Application NumberANDA209556
Structured Product Labeling (SPL ID)a0963357-1034-43ee-81bb-9c249fa29de3
Structured Product Labeling (SPL Set ID)97d35248-b28b-18b0-98a6-2d93476fb4a3
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.