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Actra-SX Capsules (Body Basics) – Unapproved Medication (2011)

Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction

Class IHigh

FDADec 19, 2011Nationwide• Body Basics Inc

Argatroban Injection (Eagle) – Crystalline Particulates (2011)

A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.

Class IHigh

FDADec 2, 2011NJ• Eagle Pharmaceuticals Inc.

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Actra-SX Capsules (Body Basics) – Unapproved Medication (2011)

Argatroban Injection (Eagle) – Crystalline Particulates (2011)

Cole Slaw (McClure's) – Mayonnaise Ingredient Details (2011)

Broccoli & Cauliflower Salad (McClure's) – Undeclared Allergens (2011)

Potato Salad (McClure's) – Salad Dressing Details (2011)

Walnut Cinnamon Streusel Cake (McClure's) – Undeclared Walnuts (2011)

Egg Salad (McClure's) – Mayonnaise Ingredient Details (2011)

Macaroni Salad (McClure's) – Incomplete Ingredients (2011)

Apple Cinnamon Streusel Cake (McClure's) – Undeclared Walnuts (2011)

Chicken Salad (McClure's) – Mayonnaise Ingredient Details (2011)

Taztia XT Capsules (Shamrock) – Label Mix-up (2011)

Metformin ER Tablets (Shamrock) – Incorrect Release Labeling (2011)

Oxycodone HCl Concentrate (Shamrock) – Label Mix-up (2011)

Dulce De Leche Ice Cream Base (Indalco) - Potential Contamination (2011)

Chocolate Mix (Raymond Hadley) – undeclared milk (2011)

Chocolate Cake Mix (Raymond Hadley) – undeclared milk (2011)

White Cake Mix (Raymond Hadley) – undeclared milk (2011)

Pancake & Biscuit Mix (Raymond Hadley) – undeclared milk (2011)

Yellow Cake Mix (Raymond Hadley) – undeclared milk (2011)

Morphine Sulfate IR 30mg (Physicians Total Care) – label mix-up (2010)