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Dr. Ming's Chinese Capsule (Slim Beauty USA) – Undeclared Ingredients (2013)

Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and phenolphthalein. Sibutramine and phenolphthalein are not currently marketed in the United States, making this product an unapproved new drug.

Class IHigh

FDADec 10, 2013Nationwide• Slim Beauty USA

Dream Body Slimming Capsule (Slim Beauty USA) – Undeclared Sibutramine (2013)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine and . Sibutramine is not currently marketed in the United States, making this product an unapproved new drug.

Class I

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Dr. Ming's Chinese Capsule (Slim Beauty USA) – Undeclared Ingredients (2013)

Dream Body Slimming Capsule (Slim Beauty USA) – Undeclared Sibutramine (2013)

Magic Slim Capsules (Slim Beauty USA) – Undeclared Ingredients (2013)

Trelstar Injectable Suspension (Actavis) – Labeling Error (2013)

Folic Acid Injection (Fresenius Kabi) – Impurity Specifications (2013)

Qnasl Nasal Aerosol (Teva) – Defective Delivery System (2013)

Sodium Chloride Injection (B. Braun) – Incorrect Bar Code (2013)

Pantaprazole Sodium Tablets (Wockhardt) – Dissolution Failure (2013)

Niacin Extended Release Tablets (Teva) – Tablet Defect (2013)

Mercuroclear Antiseptic (Humco) – Microbial Contamination (2013)

EstroPlus Supplement (Perrigo) – contamination risk (2013)

Dr. Sheffield Antibiotic Ointment (Sheffield) – Microbial Contamination (2013)

Enzyme Supplements (Source Naturals) – contamination risk (2013)

Family Wellness Antibiotic Ointment (Sheffield) – Microbial Contamination (2013)

Dollar General Antibiotic Ointment (Sheffield) – Microbial Contamination (2013)

Carisoprodol Tablets (Physicians Total Care) – Foreign Substance (2013)

Sodium Chloride Injection (Baxter) – Particulate Matter Risk (2013)

Sodium Chloride Injection (B. Braun) – Particulate Matter Risk (2013)

Cefazolin Injection (B. Braun) – Particulate Matter Risk (2013)

15% Amino Acids Injection (B. Braun) – Particulate Matter Risk (2013)