Product Recalls in 2013

NHTSA Ongoing

Aluminum Rim may Crack and/or Break

November 4, 2013 IRBIT MOTORWORKS OF AMERICA 273 units

FDA Drug Class I Terminated

Hydravax High Potency Diuretic Weight Loss Solution, Pharmaceutical Grade, 45 capsules per bottle, Dietary Supplement, Manufactured and Distributed by Metabolic Nutrition, Sunrise, Florida, www.metabo

November 4, 2013 IQ Formulations, LLC

FDA Drug Class I Terminated

Soliris (eculizumab) Concentrated Solution for Intravenous Infusion Only, 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only, Manufactured by: Alexion Pharmaceuticals, Inc., Cheshire, CT 06410,

November 4, 2013 Alexion Pharmaceuticals, Inc. 21,661 vials units

FDA Drug Class III Terminated

Glucotrol XL (glipizide) extended release tablets, 5 mg, 100 count bottles, Rx only, Distributed by Roerig, Division of Pfizer Inc, NY, NY --- NDC 0049-1550-66

November 4, 2013 Pfizer Inc. 14,357 bottles units

FDA Drug Class III Terminated

Glipizide XL (glipizide) extended release tablets, 5 mg , 500 count bottles, Rx only, Distributed by: Greenstone Ltd., Peapack, NJ --- NDC 59762-5032-2

November 4, 2013 Greenstone Llc 22,529 bottles units

FDA Food Class I Terminated

Trader Giotto's CAESAR Salad with Caesar Dressing; Perishable, keep refrigerated. Packaged in Net Wt. 8.5 oz (241 g) plastic clamshell. Manufactured for Trader Joe's Manufactured by Ghiringhelli

November 3, 2013 Ghiringhelli Specialty Foods Inc. 709 units units

FDA Food Class II Terminated

Mixed Seed Brittle ("Pepitoria Mixed"), in cellophane packages, Net Wt. 2oz (57g), UPC 6 61444 00017 1.

November 1, 2013 Las Trojes 6,750 units units

FDA Drug Class II Terminated

Novarel (IM)

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Drug Class II Terminated

Sodium Bicarbonate 8.4% inj.

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Drug Class II Terminated

Cyano B-12 p-f 1000mcg/ml

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Drug Class II Terminated

Voriconazole 1% opthal

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Food Class I Terminated

Bremer Garlic Shrimp MEAL IN MINUTES Pasta in Garlic Sauce with Broccoli, Shrimp, Corn and Carrots 21 oz bags, CONTAINS: WHEAT, MILK, CRUSTACEAN SHELLFISH (SHRIMP) Distributed by ALDI Inc., Batavia, I

November 1, 2013 Gourmet Express LLC 7,920/21 oz bags units

FDA Food Class II Terminated

Digestive Enzymes, 60 Capsules/Bottle under the following brand names: 21st Century Digestive Enzymes, 60 Capsules/Bottle. HyVee Digestive Eymes, 60 Capsules/Bottle.

November 1, 2013 21st Century Healthcare, Inc. 6483 bottles units

FDA Drug Class II Terminated

Cyanocobalamin 100mcg/ml injection

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Drug Class II Terminated

Methylcobalamin

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Food Class II Terminated

Pumpkin Seed Brittle ("Pepitoria"), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 0000 5 8.

November 1, 2013 Las Trojes 1,700 units units

FDA Drug Class II Terminated

Ethanol 20% ophthal.

November 1, 2013 Natures Pharmacy & Compounding Center

NHTSA Ongoing

Wiper Switch May Fail/FMVSS 104

November 1, 2013 Toyota Motor Engineering & Manufacturing 9,795 units

FDA Drug Class II Terminated

Dexamethosone/Tobramycin pf 0.1%/0.3% ophthalmic

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Drug Class II Terminated

Papaverine 12mg/phent 1mg/Pros 9mcq/ml

November 1, 2013 Natures Pharmacy & Compounding Center

NHTSA Ongoing

Bracket attaching the axle may break

November 1, 2013 ALTEC INDUSTRIES INC. 682 units

FDA Food Class II Terminated

Sesame Seed Brittle ("Pepitoria De Ajonjoli"), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 00006 5.

November 1, 2013 Las Trojes 3,175 units units

NHTSA Ongoing

Brakes may Unexpectedly Apply

November 1, 2013 HONDA (AMERICAN HONDA MOTOR CO.) 344,187 units

FDA Drug Class II Terminated

Tacrolimus (H20-based) 0.03% ophth.

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Drug Class II Terminated

Tetracaine 0.5% ophth.

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Food Class II Terminated

IMT Wellness Legume Digest 2.0** Dietary Supplements 120 Vegetarian Capsules *** Distributed by: ANAT, LLC Bloom field, CT; in a white 150 cc bottle with white cap

November 1, 2013 ANAT, LLC 1666 Legume units

FDA Drug Class II Terminated

Triamcinolone Acetonide 3mg/ml

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Drug Class II Terminated

Voriconazole 0.5mg/ml

November 1, 2013 Natures Pharmacy & Compounding Center

NHTSA Ongoing

Weld Fracture at Locating Pins

November 1, 2013 CHEETAH CHASSIS CORPORATION 254 units

FDA Drug Class II Terminated

Folic acid (pf) 10mg/cc inj

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Drug Class II Terminated

Vit A (olive oil) 0.1% opth.

November 1, 2013 Natures Pharmacy & Compounding Center

NHTSA Ongoing

Deactivation of Passenger Frontal Air Bags

November 1, 2013 PORSCHE CARS NORTH AMERICA, INC. 81 units

FDA Drug Class II Terminated

Tacrolimus 0.02% opth. (H20-based)

November 1, 2013 Natures Pharmacy & Compounding Center

NHTSA Ongoing

Flip Seat/Possible Toe or foot pinch

November 1, 2013 A-Z Bus Sales, Inc. 402 units

FDA Drug Class II Terminated

5-Fluorouracil pf in methocel 1% opthal

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Drug Class II Terminated

Scopolamine 0.25 opth.

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Drug Class II Terminated

Papaverine 1nj 30mg/ml

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Drug Class II Terminated

Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) equate Infants' Pain & Fever ace

November 1, 2013 L. Perrigo Co. 108,828 bottles units

FDA Drug Class II Terminated

Acetaminophen suspension liquid, 160 mg/5 mL, dye-free cherry flavor, co-packaged with an oral dosing syringe in a carton and sold under the following: a) equaling infants' pain & fever acetaminophen

November 1, 2013 L. Perrigo Co. 143,892 bottles units

FDA Drug Class II Terminated

Pyridoxine (p-f) 100mg/ml

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Food Class II Terminated

IMT Wellness Tribulus Supreme 2.0** GI & Immune Support ** Dietary Supplements 60 Vegetarian Capsules *** Distributed by: ANAT, LLC Bloom field, CT

November 1, 2013 ANAT, LLC 1300 Tribulus units

FDA Drug Class II Terminated

Acetaminophen suspension liquid, 160 mg/5 mL, dye-free grape flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) TopCare Infants' Pain &

November 1, 2013 L. Perrigo Co. 27,504 bottles units

FDA Drug Class II Terminated

Nifedipine, extended-release tablets, 90mg 100 count blister pack, Rx only, Distributed by: GREENSTONE LLC, Pespack, NJ,07977, NDC 59762-6692-8

November 1, 2013 Greenstone Llc 21600 tablets units

FDA Drug Class II Terminated

Acetaminophen suspension liquid, 160 mg/5 mL, cherry flavor, 2 FL OZ (59 mL) bottle co-packaged with an oral dosing syringe in a carton and sold under the following: a) leader Infants' Pain & Fever ac

November 1, 2013 L. Perrigo Co. 35,136 bottles units

FDA Drug Class II Terminated

Methotrexate Intraocular 400mcg 0.1cc

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Food Class II Terminated

Peanut Brittle ("Pepitoria De Cacahuate"), in cellophane packages, Net Wt. 2 oz (57g), UPC 6 61444 00012 6.

November 1, 2013 Las Trojes 4,100 units units

FDA Drug Class II Terminated

Voriconazole 0.5mg/ml

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Drug Class II Terminated

Hydroxyprogesterone Caproate

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Drug Class II Terminated

Cyano B-12 (Cmpd) 1000mcg/ml

November 1, 2013 Natures Pharmacy & Compounding Center

FDA Drug Class II Terminated

Idoxuridine 0.1% Ophthalmic

November 1, 2013 Natures Pharmacy & Compounding Center