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Showing 61–80 of 128 results

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Libigrow Red Dragon+ (Pyramids) – Undeclared Drug Ingredients (2024)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tadalafil.

FDAMar 19, 2024Nationwide• Pyramids Wholesale Inc.

Treprostinil Injection (Par) – particulate matter (2024)

Presence of Particulate Matter.

FDAMar 4, 2024Nationwide• Par Sterile Products LLC

Methocarbamol Injection (Eugia) – particulate matter (2024)

Presence of Particulate Matter

FDAFeb 15, 2024Nationwide• Eugia US LLC

Tejocote Root Supplement (HandNatural) – Yellow Oleander Risk (2024)

Product is being recalled due to the presence of yellow oleander and its components in the product.

FDAFeb 9, 2024Nationwide• HandNatural

SCHWINNNG Herbal Supplement (Today The World) – Undeclared Nortadalafil (2024)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.

FDAFeb 6, 2024Nationwide• Today The World

Arize Herbal Supplement (Today The World) – Undeclared Nortadalafil (2024)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared nortadalafil, an ingredient found in FDA approved product for the treatment of male sexual enhancement, making this drug an unapproved drug.

FDAFeb 6, 2024Nationwide• Today The World

Sustain Herbal Supplement (Today The World) – Undeclared Tadalafil (2024)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this drug an unapproved drug.

FDAFeb 6, 2024Nationwide• Today The World

To the Moon Capsules (Integrity) – Undeclared Sildenafil (2024)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.

FDAFeb 1, 2024Nationwide• Integrity Products

RAM IT Horny Goat Weed Capsules (Integrity) – Undeclared Sildenafil (2024)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil.

FDAFeb 1, 2024Nationwide• Integrity Products

Robitussin Honey CF Max Non-Drowsy (Haleon) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Products

FDADec 26, 2023Nationwide• Haleon US Holdings LLC

Robitussin Honey CF Max Nighttime (Haleon) – Microbial Contamination (2023)

Microbial Contamination of Non-Sterile Products

FDADec 26, 2023Nationwide• Haleon US Holdings LLC

Sodium Bicarbonate Injection (Pfizer) – Glass Particulate Matter (2023)

Presence of Particulate Matter; identified as glass

FDADec 21, 2023Nationwide• Pfizer Inc.

Sodium Bicarbonate Injection (Pfizer) – Glass Particulate Matter (2023)

Presence of Particulate Matter; identified as glass

FDADec 21, 2023Nationwide• Pfizer Inc.

Bleomycin Injection (Pfizer) – Glass Particulate Matter (2023)

Presence of particulate matter: glass

FDADec 21, 2023Nationwide• PFIZER

Atropine Sulfate Injection (Pfizer) – Glass Particulate Matter (2023)

Presence of Particulate Matter; identified as glass

FDADec 21, 2023Nationwide• Pfizer Inc.

Magnum XXL Capsules (Meta Herbal) – Undeclared Sildenafil (2023)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.

FDANov 29, 2023Nationwide• Meta Herbal

SANDIMMUNE Oral Solution (Novartis) – Crystallization Risk (2023)

Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals

FDANov 22, 2023Nationwide• Novartis Pharmaceuticals Corporation

SugarMD Glucose Support Capsules (SUGARMDS) – Undeclared Medication (2023)

MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide

FDANov 8, 2023Nationwide• SUGARMDS LLC

Sodium Bicarbonate Injection (Exela Pharma) – Particulate Issue (2023)

Presence of Particulate Matter: Silicone

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

ELCYS Injection (Exela Pharma) – Particulate Contamination (2023)

Presence of Particulate Matter: Silicone

FDAOct 18, 2023Nationwide• Exela Pharma Sciences LLC

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