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Showing 121–128 of 128 results

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Sodium Bicarbonate Injection (Hospira) – Insect Contamination (2016)

Presence of Particulate Matter: particulate matter identified as an insect in one vial.

FDAMar 18, 2016Nationwide• Hospira Inc.

Human Chorionic Gonadotropin (Complete Pharmacy) – Mold Contamination (2015)

Non-sterility: presence of mold confirmed by outside laboratory at the 14 day culture.

FDADec 29, 2015FL• Complete Pharmacy and Medical Solutions LLC

APEXXX Tablets (Nuway) – Unapproved Supplement (2015)

Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug.

Class I

FDADec 23, 2015Nationwide• Nuway Distributors, LLC

Vitamin D3 Supplement (Glades Drugs) – Superpotent Drug (2015)

Superpotent Drug: The vitamin supplement contains an extremely high level of vitamin D3 (Cholecalciferol).

FDANov 6, 2015GA, NY• Glades Drugs Inc.

Miracle Rock 48 (The One Minute Miracle) – undeclared drug ingredient (2015)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Miracle Rock 48 was found to contain undeclared thiosildenafil, an analogue of an FDA approved drug for male erectile dysfunchtion making this product an unapproved drug.

FDAAug 27, 2015Nationwide• The One Minute Miracle Inc

Miracle Diet Capsules (One Minute Miracle) – undeclared ingredient (2015)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Miracle Diet 30 was found to contain undeclared phenolphthalein, a drug product once contained in over-the-counter laxatives but was taken off the U.S. market due to safety concerns, making this product an unapproved drug.

FDAAug 27, 2015Nationwide• The One Minute Miracle Inc

Akttive Fat Burner Gold (Life and More) – undeclared ingredients (2015)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.

FDAJul 13, 2015Nationwide• Life and More LLC

Zero Xtreme Fat Burner (Xtreme Z) – undeclared ingredients (2015)

Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.

FDAJul 2, 2015Nationwide• XTREME Z DISTRIBUTORS INC

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