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Citron Tea (Hee Chang) - Undeclared Allergens (2018)

During a FDA foreign inspection, it was found that four products did not declare allergens.

Class IIModerate

FDAMay 18, 2018CA, IN• Hee Chang Dairy & Food Co., LTD

Poseidon Xtreme Platinum (Shoreside Enterprises) – undeclared ingredients (2018)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Class IHigh

FDAMay 17, 2018

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Citron Tea (Hee Chang) - Undeclared Allergens (2018)

Poseidon Xtreme Platinum (Shoreside Enterprises) – undeclared ingredients (2018)

Colorations Extra-Large Crayons – Laceration Hazard (2018)

SuperMax Triple Slides (Play and Park) – Entrapment Risk (2018)

Option Systems Hand Wash (Inopak) – microbial contamination (2018)

Regency Ultimate Gas Stoves – Explosion Injury Risk (2018)

NY Thermal Boilers – Carbon Monoxide Risk (2018)

Ambiano Mini Deep Fryers – Fire Burn Risk (2018)

Illy Coffee Cans – Injury Hazard (2018)

Women's Scarves – Flammability Violation (2018)

Solar Defense Sunscreen SPF50 (Milbar) – Manufacturing Deviation (2018)

MD Complete Clarifying Cleanser (Milbar) – Manufacturing Deviation (2018)

Penguin Cardigan Set (Carter's) – Choking Risk (2018)

Ampicillin Sulbactam Injection (AuroMedics) – Rubber Particles (2018)

Mandoline Slicers (Sharper Image & Frigidaire) – laceration hazard (2018)

Parade Salsa Hot (Giovanni) – glass contamination (2018)

Parade Salsa Medium (Giovanni) – glass contamination (2018)

Parade Salsa Mild (Giovanni) – glass contamination (2018)

Protein Key Meals (Wysong) – Undeclared Soy (2018)

Protein Key Meals (Wysong) – Undeclared Soy (2018)