Tadalafil USP
CGMP Deviations:Noted during FDA inspection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling Not Elsewhere Classified: Misbranding.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
Tadalafil SR 7 mg Capsules packed in 8,13, 20, 30, 40 or 60 dram screw top pill bottle, Carie Boyd's Prescription Shop 122 Grapevine Hwy. Hurst, TX 76054. NDC 99999-9970-88
Drug: Tadalafil
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
CGMP Deviations:Noted during FDA inspection
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
cGMP Deviations
Product Mix-up: Incorrect Product Formulation
Labeling Not Elsewhere Classified: Misbranding.
Labeling Not Elsewhere Classified: Misbranding.
Labeling Not Elsewhere Classified: Misbranding.
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