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B-50 Capsules (Mira) – Unapproved Steroid (2013)

Marketed without an Approved NDA/ANDA; product found to contain methasterone and dimethazine which are steroid and/or steroid-like drug ingredients, making it an unapproved new drug

Class IHigh

FDAJul 22, 2013Nationwide• Mira Health Products Ltd.

New Sun Immune 101 (New Sun Inc) – E. coli Contamination (2013)

E. coli

Positive E.coli

Class IIModerate

FDAJul 22, 2013AL, CA, CO +28 more• New Sun Inc

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B-50 Capsules (Mira) – Unapproved Steroid (2013)

New Sun Immune 101 (New Sun Inc) – E. coli Contamination (2013)

Tagitol V Barium Sulfate (Bracco) – Failed Stability Test (2013)

Volcano Male Enhancement Liquid (Myson) – Unapproved Supplement (2013)

Volcano Male Enhancement (Myson) – Unapproved Supplement (2013)

Esbelin Siloutte Mezcal (Herbal Give Care) – Undeclared Sibutramine (2013)

Esbelder Siloutte (Herbal Give Care) – Undeclared Sibutramine (2013)

Esbelder Man (Herbal Give Care) – Undeclared Sibutramine (2013)

Esbelder Fem (Herbal Give Care) – Undeclared Sibutramine (2013)

Oxycodone/Acetaminophen Capsules (Watson) – Subpotent Drug (2013)

TUMS Ultra (GlaxoSmithKline) – Foreign Tablets (2013)

Acyclovir Tablets (Apotex) – Particulate Contamination (2013)

Nystatin Oral Suspension (VistaPharm) – Impurities Failure (2013)

Ashwagandha Extract (NOW Foods) – undeclared licorice (2013)

DayQuil Sinex (Procter & Gamble) – Packaging Defect (2013)

Colestipol HCL Micronized Tablet (Aidapak) – Label Mixup (2013)

CHOLECALCIFEROL Tablet 1000 Units (Aidapak Services) – Label Mixup (2013)

Lithium Carbonate ER Tablet (Aidapak Services) – Label Mixup (2013)

Mycophenolic Acid DR 180mg (Aidapak) – Label Mixup (2013)

Flecainide Acetate (Aidapak Services) – Label Mixup (2013)