Product Safety Recalls

Product Recall Tracker

TADALAFIL Recall D-0526-2023

Description: Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC 68788-8153-7

TADALAFIL Recall D-0526-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-0526-2023
Event ID91952
Active SubstanceTADALAFIL
Drug RouteORAL
DistributionUSA Nationwide
Quantity32 Bottles
Recall ReasoncGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Drug ClassificationClass II
Drug Code Info20230412
Product NDC68788-8153
Product NUIN0000175599 N0000020026
Pharma Class (EPC)Phosphodiesterase 5 Inhibitor [EPC]
Recall Initiation Date20230323
Report Date20230412
Classification Date20230406
Address1250 N Lakeview Ave Ste O
Anaheim, CA 92807-1801
United States
Recalling FirmPreferred Pharmaceuticals, Inc.
Initial Notification Letter
Unique Ingredient Identifier742SXX0ICT
Drug Application NumberANDA209167
Structured Product Labeling (SPL ID)affacb88-4af3-4ce9-961b-7fc37b169e9a
Structured Product Labeling (SPL Set ID)affacb88-4af3-4ce9-961b-7fc37b169e9a
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