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Natural Remedies Active Male (Y-O Management) – undeclared drug (2020)

Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction

Class IHigh

FDAMar 16, 2020GA, IN, TX• Y-O Management LLC, dba Natural Remedy Store

Doxycycline Capsules (Sun Pharmaceutical) – manufacturing issue (2020)

CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Practice conditions.

Class IIModerate

FDAMar 13, 2020Nationwide

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Natural Remedies Active Male (Y-O Management) – undeclared drug (2020)

Doxycycline Capsules (Sun Pharmaceutical) – manufacturing issue (2020)

Vancomycin Opthal Drops (Medical Center Pharmacy) – sterility concerns (2020)

Doxycycline Capsules (Sun Pharmaceutical) – manufacturing deviation (2020)

Morphine Cassette (Medical Center Pharmacy) – sterility concerns (2020)

Gentamicin/Bacitracin Irrigation (Medical Center) – sterility risk (2020)

Mitomycin Eye Drops (Medical Center Pharmacy) – sterility concerns (2020)

Albumin Eye Drops (Medical Center Pharmacy) – sterility concerns (2020)

Pantoprazole Tablets (Jubilant Cadista) – tablet discoloration (2020)

Atorvastatin Tablets (Sun Pharmaceutical) – foreign substance (2020)

Sotalol HCL Tablets (Mylan) – Metal Particle Contamination (2020)

Bekyree Birth Control (Lupin) – Content Uniformity Failure (2020)

Levonorgestrel Estradiol Tablets (Lupin) – content uniformity (2020)

Acetaminophen 500mg (Pharma Pac) – Foreign Tablet Mixup (2020)

Theophylline Extended-Release (Nostrum) – Labeling Errors (2020)

Sodium Chloride Injection (Fresenius) – Sterilization Issue (2020)

Epinephrine Auto-Injector (Teva) – Trigger Force Problem (2020)

Prednisone Tablets (Par) – Incorrect Expiration Date (2020)

Daytrana Patch 15mg (Noven) – Delivery System Defect (2020)

Daytrana Patches (Noven) – Delivery System Defect (2020)