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CALCIPOTRIENE HYDRATE Recall D-1170-2022

Description: Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl. oz.) bottle, Manufactured by: HI-TECH PHARMACAL CO., INC., Amityville, N.Y. 11701. NDC: 50383-732-02

CALCIPOTRIENE HYDRATE Recall D-1170-2022 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1170-2022
Event ID90442
BrandCALCIPOTRIENE
Generic NameCALCIPOTRIENE
ManufacturerCALCIPOTRIENE
Original Package?1
Active SubstanceCALCIPOTRIENE HYDRATE
Drug RouteTOPICAL
DistributionNationwide in the U.S.
Quantity2,736 Bottles
Recall ReasonDefective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Drug ClassificationClass II
Drug Code Info20220706
Product NDC50383-732
Recall Initiation Date20220610
Report Date20220706
Classification Date20220629
Address1925 W Field Ct Ste 300
Lake Forest, IL 60045-4862
United States
Recalling FirmAkorn, Inc.
Initial Notification Letter
Unique Ingredient IdentifierS7499TYY6G
Drug Application NumberANDA077579
Structured Product Labeling (SPL ID)e2844787-f986-4554-bae1-9e4050695edc
Structured Product Labeling (SPL Set ID)53c9942a-e861-493f-95c2-53446bc5f06d
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