Product Recalls in 2012

FDA Food Class I Terminated

***Fresh Point***Fresh Cuts***Fruit Mango/Papaya Diced***2 x 5lb Tray***Net. Wt. 10 lb.***

September 27, 2012 FreshPoint South Florida 1 case units

FDA Drug Class III Terminated

CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed

September 27, 2012 Genentech Inc 1128 bottles units

FDA Drug Class II Terminated

Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05

September 27, 2012 Dr. Reddy's Laboratories, Inc. 1512 bottles units

FDA Food Class I Terminated

Newman's Own Organics brand Newman-O's Peanut Butter Creme Filled Chocolate Cookies 8oz/6 pack, Unit UPC#7 57645 02170 8, Case UPC#7 57645 02171 5; 13oz/6 pack, Unit UPC# 7 57645 02150 0, Case U

September 27, 2012 Newman's Own Organics 4,609 cases or 27,654 packages total; With expansion: 146,213 cases units

FDA Drug Class II Terminated

MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.

September 27, 2012 Fresenius Kabi USA, LLC 101,200 Vials units

FDA Food Class I Terminated

Label reads in part "*** ORGANIC Alden's ICE CREAM PEANUT BUTTER 'n CHIP 1.5 QTS ***" upc 0 72609 74191 2.

September 27, 2012 Oregon Ice Cream, LLC 71,312 cs (3 retail units (1.5 quarts/cs) units

FDA Food Class I Terminated

Harry & David Creamy Caramel Peanut Spread, 12 oz. jars, labeled in part: "HARRY & DAVID CREAMY CARAMEL PEANUT SPREAD***NET WT 12 OZ (340g)***INGREDIENTS: ROASTEDPEANUTS, SUGAR, CARAMEL COMPOUND***MAD

September 27, 2012 Harry and David Operations, Inc. 5,928 - 12 oz. jars units

FDA Drug Class II Terminated

Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center N/A units

FDA Drug Class II Terminated

Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 3,321 vials units

FDA Drug Class I Terminated

Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 5130 vials units

FDA Food Class I Terminated

Evolution Fresh brand Almond Butter in individual 2-oz containers, UPC 726111926838. Label reads in part, perishable. keep refrigerated. ALMOND BUTTER, NET WT 2 OZ, MANUFACTURED FOR EVOLUTION FRESH,

September 26, 2012 Gretchen's Shoebox Express 8 units units

FDA Food Class II Terminated

Individual wrapper: Nature Valley Sweet & Salty Nut, granola bars, Peanut, net WT 1.2 oz (35 g) UPC 0 1600044282 5, Distributed by General Mills Sales, INC., Minneapolis, MN 55440. Ingredients: Roaste

September 26, 2012 General Mills, Inc 2511 cases ( each contains 12- 7.4 oz cartons) units

FDA Food Class I Terminated

Treasure Trove Mix, sold from Whole Foods Market Bulk Bins PLU 6922

September 26, 2012 Whole Foods Market 431 lbs. units

FDA Food Class I Terminated

Justin's Classic Peanut Butter, 5 lb, Material Number F0004701, 45 lb Material number F0033001.

September 26, 2012 Justin's Nut Butter 246 units units

FDA Drug Class II Terminated

Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 8919 vials units

CPSC Ongoing

Big Lots Recalls Garden Swings Due to Fall Hazard

September 26, 2012 Anji Jiayi Garden Supplies Company, Xiaofeng Town, China About 6,900 units

FDA Drug Class II Terminated

Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 165 vials units

FDA Drug Class II Terminated

Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 56,655 vials units

FDA Drug Class II Terminated

Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 7055 vials units

FDA Food Class I Terminated

Natural Classic Peanut Butter 16 oz UPC 855188003004, 1.15 oz Squeeze Packs UPC 855188003011.

September 26, 2012 Justin's Nut Butter 12,401 units units

FDA Food Class I Terminated

Organic Dark Chocolate Peanut Butter Cups 1.4 oz, UPC 894455000254.

September 26, 2012 Justin's Nut Butter 1130 units units

FDA Food Class I Terminated

Natural Honey Peanut Butter; 16 oz jars, UPC 855188003035; Natural Honey Peanut Butter Squeeze Packs 0.5 oz, UPC 894455000391, Natural Honey Peanut Butter Squeeze Packs 1.15 oz, UPC 855188003042.

September 26, 2012 Justin's Nut Butter 129,923 units units

FDA Drug Class II Terminated

Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 54 vials units

NHTSA Ongoing

LP Hose May Contact Tire

September 26, 2012 HEARTLAND RECREATIONAL VEHICLES, LLC 68 units

FDA Food Class I Terminated

Organic Classic Peanut Butter 16 oz UPC 894455000117, 1.15 oz squeeze packs UPC 894455000087.

September 26, 2012 Justin's Nut Butter 36,111 units units

FDA Food Class I Terminated

Natural Chocolate Peanut Butter 16 oz UPC 894455000476, 1.15 oz squeeze packs UPC 894455000506.

September 26, 2012 Justin's Nut Butter 21,010 units units

FDA Food Class I Terminated

Evolution Fresh brand Cinnamon and Apple Almond Butter Sandwiches in plastic wrap, NET WT 5.75 oz., UPC 726111926371. Label reads in part, perishable. keep refrigerated. CINNAMON APPLE & ALMOND BUTTE

September 26, 2012 Gretchen's Shoebox Express 12 units units

FDA Drug Class II Terminated

Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 20 vials units

FDA Drug Class II Terminated

Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 2747 vials units

FDA Drug Class II Terminated

Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center N/A units

FDA Drug Class I Terminated

Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 3822 vials units

FDA Drug Class II Terminated

Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 10,865 vials units

FDA Food Class I Terminated

Organic Milk Chocolate Peanut Butter Cups 1.4 oz, UPC 894455000247.

September 26, 2012 Justin's Nut Butter 1,130 units units

FDA Food Class I Terminated

Peanut Butter Power Chews sold as a bulk item through Whole Foods Market self serve bins, PLU 9663

September 26, 2012 Whole Foods Market 18 lbs. units

FDA Drug Class I Terminated

Methylprednisolone Acetate (PF) 80 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 23,897 vials units

FDA Drug Class I Terminated

Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 9062 vials units

FDA Drug Class II Terminated

Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center N/A units

FDA Food Class I Terminated

Organic Honey Peanut Butter 16 oz UPC 894455000001, 1.15 oz squeeze packs UPC 894455000094.

September 26, 2012 Justin's Nut Butter 48,955 units units

FDA Drug Class II Terminated

Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/m

September 26, 2012 New England Compounding Center N/A units

FDA Food Class I Terminated

Fruit Mango Peeled & Halved, Ready-To-Eat Product, 2, 2.5-lb trays per case

September 25, 2012 FreshPoint Central Florida 123 trays / 2/2.5# units

NHTSA Ongoing

Fuel Tank Venting Compressed Natural Gas

September 25, 2012 Vehicle Production Group LLC 435 units

FDA Food Class I Terminated

SunRidge Farms Treasure Trove Mix. Packed in 20 pound case. UPC code: 086700301104 Manufactured by Falcon Trading Company, Inc. dba SunRidge Farms 423 Salinas Road Royal Oaks, CA 95076

September 25, 2012 Falcon Trading Co., Inc. 50 cases units

NHTSA Ongoing

Brake Chamber Interfering with Upper Control Arms

September 25, 2012 NEWMAR CORPORATION 278 units

FDA Food Class I Terminated

SunRidge Organic Crunchy Peanut Butter with salt Packed in 35 pound tub UPC code: 086700161852 Manufactured by Falcon Trading Company, Inc. dba SunRidge Farms 423 Salinas Road Royal Oaks, CA 950

September 25, 2012 Falcon Trading Co., Inc. N/A units

CPSC Ongoing

Specialized Bicycle Components Recalls Bicycles Due to Fall and Injury Hazards

September 25, 2012 Kinesis, of China About 12,000 units

FDA Food Class I Terminated

SunRidge Chocolate Double Decker Chew Packed in 10 pound case. UPC code: 086700211175 Manufactured by Falcon Trading Company, Inc. dba SunRidge Farms 423 Salinas Road Royal Oaks, CA 95076

September 25, 2012 Falcon Trading Co., Inc. N/A units

FDA Food Class I Terminated

***Publix***Hearts of Romaine***Chopped Hearts of Romaine***Triple Washed***& Ready to Eat***No Preservatives***NET WT 10 OZ (284g)***

September 25, 2012 Publix Super Markets 763 cases units

FDA Food Class I Terminated

Fruit Mango Peeled & Diced 1/4, Ready-To-Eat Product, 2, 5-LB Trays per case

September 25, 2012 FreshPoint Central Florida 174 trays / 2/5LB units

FDA Food Class I Terminated

SunRidge Candy - Peanut Butter Power Chews. Packed in 10 pound case. UPC code: 086700902004 Manufactured by Falcon Trading Company, Inc. dba SunRidge Farms 423 Salinas Road Royal Oaks, CA 9507

September 25, 2012 Falcon Trading Co., Inc. 1846 cases units

FDA Food Class I Terminated

Fruit Mango Whole Peeled, Ready-To-Eat Product, 2, 5-LB Trays per case

September 25, 2012 FreshPoint Central Florida 4 trays / 2/5LB units