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HYDROCORTISONE BUTYRATE Recall D-0703-2022

Description: Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04.

HYDROCORTISONE BUTYRATE Recall D-0703-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0703-2022
Event ID89798
BrandHYDROCORTISONE BUTYRATE
Generic NameHYDROCORTISONE BUTYRATE LOTION
ManufacturerHYDROCORTISONE BUTYRATE LOTION
Original Package?1
Active SubstanceHYDROCORTISONE BUTYRATE
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity6874 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 NDC70512-032
Drug UPC0370512032043
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)b8b8c6ab-f51c-036c-e053-2995a90a9e5b
Structured Product Labeling (SPL Set ID)824c329b-1556-206c-e053-2a91aa0a7742
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