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Epinephrine HCl Sodium Chloride (Pharmedium) – Particulate Matter (2015)

Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.

Class IHigh

FDAApr 13, 2015Nationwide• Pharmedium Services, LLC

Ketorolac Tromethamine 60mg (Hospira) – Crystallization (2015)

Crystallization

Class IIModerate

FDAApr 13, 2015Nationwide• Hospira Inc.

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Epinephrine HCl Sodium Chloride (Pharmedium) – Particulate Matter (2015)

Ketorolac Tromethamine 60mg (Hospira) – Crystallization (2015)

Heparin Sodium Injection (Pharmedium) – Particulate Matter (2015)

Fluoxetine Capsules 10mg (Teva) – Chemical Contamination (2015)

Fluoxetine Capsules 20mg (Teva) – Chemical Contamination (2015)

Oxytocin 5% Dextrose Injection (Pharmedium) – Particulate Matter (2015)

Ketorolac Tromethamine 30mg (Hospira) – Crystallization (2015)

Testosterone Cypionate (Stroheckers) – Incorrect Formulation (2015)

MONISTAT 1 SIMPLE CURE (Medtech) – Unapproved Drug Marketing (2015)

Lose Weight Fast W700 (Uber Vita) – Packaging Error (2015)

Hydroxyzine Hydrochloride Oral Solution (Akorn) – Impurity Specs Failure (2015)

Sodium Chloride Injection 100mL (Hospira) – Port Leakage Risk (2015)

Olanzapine Tablets (Apotex) – Subpotent Medication (2015)

Hydroxyzine Hydrochloride Oral Solution (Akorn) – Impurity Specs Failure (2015)

Olanzapine Orally Disintegrating Tablets 10mg (Apotex) – Subpotent Drug (2015)

Olanzapine Tablets (Apotex) – Subpotent Medication (2015)

Acarbose Tablets (Boehringer) – Subpotent Drug (2015)

C-Topical Cocaine Solution (Cody Labs) – Labeling Error (2015)

Cartia XT (Actavis) – Foreign Substance Presence (2015)

Fexofenadine Tablets (Mylan) – Impurity Specification (2015)