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Clonidine Tablets 0.2mg (Mutual) – manufacturing deviation (2015)

cGMP Deviations; Clonidine hydrochloride drug substance used in the manufacturing of this product, was dispensed in unauthorized rooms by the drug substance manufacturer

Class IIModerate

FDAJul 9, 2015Nationwide• Mutual Pharmaceutical Company, Inc.

Nitroglycerin Patch 0.2mg (Kremers Urban) – impurity issue (2015)

Failed Impurities/Degradation Specifications: failed specification for unknown impurity at the 24 month stability testing.

Class IIModerate

FDAJul 7, 2015Nationwide

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Clonidine Tablets 0.2mg (Mutual) – manufacturing deviation (2015)

Nitroglycerin Patch 0.2mg (Kremers Urban) – impurity issue (2015)

Nitroglycerin Patch 0.4mg (Kremers Urban) – impurity issue (2015)

Coenzyme Q-10 (Mason Vitamins) – Incorrect Labeling (2015)

DHEA Capsules (Chemi-source) – Dosage Mislabeling (2015)

Thera-Gesic Pain Cream (BioComp) – subpotent ingredients (2015)

CVS Black Cherry Cough Drops (Bestco) – mixed product (2015)

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

Sodium Chloride Injection (Hospira) – sterility leak (2015)

Capecitabine Tablets (Mylan) – dissolution failure (2015)

Panadol Extra Strength (GlaxoSmithKline) – dissolution failure (2015)

HydrOXYzine Tablets (Qualitest) – unreadable tablet codes (2015)

Hydroxyprogesterone Caproate (Apothecary Shoppe) – sterility concern (2015)

Chorionic Gonad HCG Injection (Apothecary) – sterility monitoring (2015)

SIU-Papav/Phent 30/1 mg Injection (Apothecary Shoppe) – sterility concern (2015)

Papav/Phentol Injection (Apothecary) – sterility monitoring (2015)

Tri-Mix Injection (Apothecary) – sterility monitoring (2015)

Methylcobalamin 1000 mcg/mL Injection (Apothecary Shoppe) – sterility concern (2015)

Prostaglandin E1 500 mcg/mL Injection (Apothecary Shoppe) – sterility concern (2015)

SIU-Phent .8/PGE1 Injection (Apothecary Shoppe) – sterility concern (2015)