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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0526-2023 |
Event ID | 91952 |
Brand | TADALAFIL |
Generic Name | TADALAFIL |
Manufacturer | TADALAFIL |
Active Substance | TADALAFIL |
Drug Route | ORAL |
Distribution | USA Nationwide |
Quantity | 32 Bottles |
Recall Reason | cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. |
Drug Classification | Class II |
Drug Code Info | 20230412 |
Product NDC | 68788-8153 |
Product NUI | N0000175599 N0000020026 |
Pharma Class (EPC) | Phosphodiesterase 5 Inhibitor [EPC] |
Recall Initiation Date | 20230323 |
Report Date | 20230412 |
Classification Date | 20230406 |
Address | 1250 N Lakeview Ave Ste O Anaheim, CA 92807-1801 United States |
Recalling Firm | Preferred Pharmaceuticals, Inc. |
Initial Notification | Letter |
Unique Ingredient Identifier | 742SXX0ICT |
Drug Application Number | ANDA209167 |
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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