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Lodrane D (Valeant) – Mislabeled Carton Packaging (2016)

Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.

Class IIILow

FDAMay 23, 2016Nationwide• Valeant Pharmaceuticals North America LLC

Nitrofurantoin Oral Suspension (Nostrum) – Failed Dissolution Test (2016)

Failed Dissolution Specifications

Class IIModerate

FDAMay 23, 2016Nationwide• Nostrum Laboratories, Inc.

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Lodrane D (Valeant) – Mislabeled Carton Packaging (2016)

Nitrofurantoin Oral Suspension (Nostrum) – Failed Dissolution Test (2016)

Amino Gold Capsules (Ultimate Nutrition) – Undeclared Milk (2016)

Amino Gold Tablets (Ultimate Nutrition) – Undeclared Milk (2016)

Amino Gold Tablets (Ultimate Nutrition) – Undeclared Milk (2016)

Oxycodone HCl Oral Solution (West-Ward) – Failed Impurities Test (2016)

Doxycycline Capsules 40mg (Galderma) – Missing Lot Details (2016)

Divalproex Sodium Tablets (Teva) – Failed Tablet Specs (2016)

Mycophenolate Mofetil Powder (Attix) – FDA Registration Issue (2016)

Levocarnitine 100mg/ml Vials (Well Care) – Sterility Concerns (2016)

Quad-Mix #1 Vials (Well Care) – Sterility Concerns (2016)

Tri-Mix #3 Vials (Well Care) – Sterility Concerns (2016)

Testosterone Cypionate 150mg/ml Vials (Well Care) – Sterility Concerns (2016)

Testosterone Cypionate 175mg/ml Vials (Well Care) – Sterility Concerns (2016)

Alpha Lipoic Acid 25mg/mL (Well Care Compounding) – Sterility Concerns (2016)

Estradiol Cypionate 10 MG/ML (Well Care) – Sterility Concerns (2016)

Vitamin B Complex #3 (Well Care Compounding) – Sterility Concerns (2016)

Methylcobalamin 1 MG/ML (Well Care) – Sterility Concerns (2016)

Methylcobalamin 12.5MG/ML (Well Care) – Sterility Concerns (2016)

Vancomycin 50mg/mL Ophthalmic Solution (Well Care Compounding) – Sterility Concerns (2016)