Product Safety Recalls

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CLOBETASOL PROPIONATE Recall D-0700-2022

Description: Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60.

CLOBETASOL PROPIONATE Recall D-0700-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0700-2022
Event ID89798
BrandCLOBETASOL PROPIONATE CREAM
Generic NameCLOBETASOL PROPIONATE CREAM
ManufacturerCLOBETASOL PROPIONATE CREAM
Original Package?1
Active SubstanceCLOBETASOL PROPIONATE
Drug RouteTOPICAL
DistributionNationwide in the USA and Puerto Rico
Quantity26,326 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 NDC70512-028
Drug UPC0370512028602
Recall Initiation Date20220315
Report Date20220330
Classification Date20220321
Address105 Lincoln Avenue
Buena, NJ 08310
United States
Recalling FirmTeligent Pharma, Inc.
Initial Notification Letter
Unique Ingredient Identifier779619577M
Drug Application NumberANDA209974
Structured Product Labeling (SPL ID)b8bc7e18-cd15-7cb2-e053-2a95a90a2f01
Structured Product Labeling (SPL Set ID)8195648e-a744-337d-e053-2991aa0a86c2
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