Product Recalls in 2013

FDA Drug Class II Terminated

Methylprednisolone 80mg w/lidocaine 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

May 28, 2013 Main Street Family Pharmacy, LLC 2235 units units

FDA Drug Class II Terminated

Triamcinolone 40mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

May 28, 2013 Main Street Family Pharmacy, LLC 2164 units units

FDA Drug Class II Terminated

B-12 (compounded) 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

May 28, 2013 Main Street Family Pharmacy, LLC 2157 units units

FDA Drug Class II Terminated

Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR

May 27, 2013 Earthlabs, Inc. DBA Wise Woman Herbals 581x1oz bottles, 263x2 oz bottles, 20x4 oz bottles, 2x8 oz bottles, 1x16 oz bottle, 1x32 oz bottle units

FDA Food Class II Terminated

SOCKEYE SALMON: 1) "***SMOKED WILD SOCKEYE SALMON (NOVA LOX)***INGREDIENTS: Wild Sockeye Salmon, Salt, Sugar, Natural Wood Smoke. CONTAINS: SOCKEYE SALMON (FISH)***Produced By: SALMOLUX, 34100 9th

May 25, 2013 Salmolux (A Pacific Seafood Group Company) N/A units

FDA Food Class II Terminated

KETA SALMON: 1) "***ALASKAN SMOKED SALMON (NOVA LOX)***Net WT. 16 oz (454g)***INGREDIENTS: Wild Keta Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6 & Red #40, Natural Wood Smoke. CONTAINS: FISH

May 25, 2013 Salmolux (A Pacific Seafood Group Company) N/A units

FDA Food Class I Terminated

"***JENSEN'S SEATTLE STYLE SMOKED WILD PACIFIC SALMON ***JENSEN'S SMOKEHOUSE, INC.***10520 GREENWOOD AVE N***SEATTLE, WA 98133*** (206) 364-5569** SOCKEYE LOX Net Wt. 4 oz***".

May 25, 2013 Salmolux (A Pacific Seafood Group Company) total 4930 lbs. units

FDA Food Class II Terminated

ATLANTIC SALMON: 1) "***Raley's***NOVA LOX***NET WT 4 OZ (113 g)***INGREDIENTS: ATLANTIC SALMON (FARM RAISED-COLOR ADDED), SALT, SUGAR, SODIUM NITRITE, NATURAL WOOD SMOKE. CONTAINS: SALMON (FISH)*

May 25, 2013 Salmolux (A Pacific Seafood Group Company) N/A units

FDA Food Class II Terminated

"***NORWEGIAN SMOKED SALMON (NOVA LOX)***Net Wt. 8 oz (227g)***INGREDIENTS: Atlantic Salmon (Farm Raised-Color Added), Salt, Sugar, Sodium Nitrite, Natural Wood Smoke. CONTAINS: FISH (SALMON)***0 1646

May 25, 2013 Salmolux (A Pacific Seafood Group Company) N/A units

FDA Drug Class I Terminated

Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single Dose Vial, Rx only, Preservative Free, APP Pharmaceuticals, LLC, Schaumburg, IL, 60173, NDC 63323-064-50

May 25, 2013 Fresenius Kabi USA, LLC 15,625 vials units

FDA Drug Class II Terminated

Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patient infusion vial, RX only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-24; Propofol Injectable Emulsion, 500 mg/50

May 25, 2013 Hospira, Inc. 94,110 vials units

FDA Food Class II Terminated

"***WILD ALASKAN NOVA LOX SMOKED SALMON***Sea Passion***INGREDIENTS: Wild Alaskan Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6, FD&C Red #40 (color enhancers), Natural Wood Smoke. CONTAINS: FI

May 25, 2013 Salmolux (A Pacific Seafood Group Company) N/A units

NHTSA Ongoing

Incorrect Tire Load Index Information/Part 567

May 24, 2013 FLEETWOOD RV, INC. 113 units

FDA Food Class II Terminated

Soy Protein Isolate; 79 bulk raw material lots and 52 finished product lots. Soy Protein Isolate was sold in bulk to two customers, both sausage manufacturers not under FDA jurisdiction. Also sold

May 24, 2013 ABCO Laboratories, Inc. 52 lots of finished products, 70 bulk raw material lots. units

NHTSA Ongoing

Roof Rack May Separate From Vehicle

May 24, 2013 YAKIMA PRODUCTS, INC. 1,369 units

FDA Food Class I Terminated

Blessing Brand Wild White EZ Peel Shrimp, 16/20 CT. 4 x 5 lbs cartons. The product is bagged in 5 lbs clear plastic bags, the only label iss on the master carton. The product is sold in a seafood

May 24, 2013 Blessing Seafood, Inc. 36,920 lbs units

FDA Food Class II Terminated

Mother Earth Products, Veggie Burger, Textured Vegetable Protein, packaged in 2-cup mylar bags, 1-quart mylar bags, 1-quart plastic jar, 1-gallon mylar bags, 5-lb mylar bags, 15-lb bulk bag, 25-lb bul

May 23, 2013 Mother Earth International LLC 210 lbs. units

NHTSA Ongoing

Solar Panel May Separate from Motorhome

May 23, 2013 FLEETWOOD RV, INC. 184 units

NHTSA Ongoing

Incorrect Federal Certification Label

May 23, 2013 Lotus Cars USA, Inc. 28 units

CPSC Ongoing

Nourison Recalls Rugs Due to Fire Hazard; Sold Exclusively at Home Depot

May 23, 2013 About 1,400 units

FDA Drug Class II Terminated

INK-EEZE Tattoo Black Label Numbing Spray, a) 0.27 oz. (8 mL), b) 2 oz. (59 mL), No Epinephrine, Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline

May 23, 2013 Indelicare LLC 2849 Bottles units

FDA Food Class II Terminated

Vegetarian Burger Mix, Item #VB 100, Pack size: 25lbs.

May 23, 2013 Good Source Incorporated 159 cases units

FDA Drug Class II Terminated

INK-EEZE Tattoo Numbing Spray, 2 oz. (59 mL), Active Ingredients: Lidocaine HCl 5% Topical Anesthetic, Distributed by: Indelicare, LLC 914 Tourmaline Drive, Newbury Park, CA 91320, (800) 611-7720, w

May 23, 2013 Indelicare LLC 683 Bottles units

FDA Food Class II Terminated

"***DIETARY SUPPLEMENT 4HB STACK Mealtime***78 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***".

May 22, 2013 Florida Nutri Labs, LLC 1982 bottles units

FDA Food Class II Terminated

Cottage Cheese with Chive distributed under the following labels and sizes: (a) Hood brand Cottage Cheese with Chive, SMALL CURD 4% MILKFAT, NET WT. 16 OZ. (453g), UPC 044100102264, HP HOOD LLC, LYNNF

May 22, 2013 H.P. Hood, LLC N/A units

FDA Food Class II Terminated

FLAV-R-PAC IQF Chopped Spinach, packaged in a 32 oz. bag, NORPAC Catalog #30238-01. The UPC is 0 48800 30238 2 The product is labeled in parts: "***FLAV R PAC***Classic Vegetables***Chopped Spina

May 22, 2013 Norpac Foods, Inc. 411 cases/6 packages/32 oz. units

NHTSA Ongoing

Throttle Cables May Hinder Steering

May 22, 2013 TRIUMPH MOTORCYCLES (AMERICA) LTD 652 units

CPSC Ongoing

Insolroll Recalls Roller Shades with Solar and Rechargeable Motors Due to Fire Hazard

May 22, 2013 Insolroll Window Shading Systems, of Louisville, Colo. About 1,500 units

FDA Food Class II Terminated

4% Cottage Cheese distributed under the following labels and sizes: (a) Hannaford brand Cottage Cheese, 4% milkfat, small curd, NET WT. 24 OZ (680g), UPC 041268114504, DISTRIBUTED BY: HANNAFORD BROS.

May 22, 2013 H.P. Hood, LLC N/A units

NHTSA Ongoing

Loss of Ambulance Electrical Power

May 22, 2013 Wheeled Coach Industries, Inc. 6 units

NHTSA Ongoing

Door Handle Spring Stiffness/FMVSS 206

May 22, 2013 PIERCE MANUFACTURING 2,006 units

FDA Food Class II Terminated

1% Low Fat Cottage Cheese distributed under the following labels and sizes: (a) Fiber One brand Lowfat Cottage Cheese, 1% Milkfat Minimum, NET WT, 16 OZ (453g), UPC 041483035585, DISTRIBUTED BY HP HOO

May 22, 2013 H.P. Hood, LLC N/A units

FDA Food Class II Terminated

"***DIETARY SUPPLEMENT 4HB STACK Bedtime***52 CAPLETS***MANUFACTURED EXCLUSIVELY FOR: Kirkland Science Labs 935 Jackson St #91810 Seattle, WA 98104-2818***".

May 22, 2013 Florida Nutri Labs, LLC 2526 bottles units

FDA Drug Class II Terminated

Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015

May 21, 2013 Baxter Healthcare Corp. N/A units

FDA Drug Class II Terminated

Zolpidem Tartrate Tablets 5 mg, 10 tablets per blister, 10 blisters per carton, 100 cartons per box, Rx Only, Manufactured for Wockhardt USA LLC., Parsippany, NJ 07054 by Wockhardt Limited, Mumbai, In

May 21, 2013 American Health Packaging 48.230 carton units units

NHTSA Ongoing

Transmission May Pop Out of Gear

May 21, 2013 TRIUMPH MOTORCYCLES (AMERICA) LTD 349 units

FDA Drug Class II Terminated

Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Cont

May 21, 2013 Baxter Healthcare Corp. N/A units

CPSC Ongoing

Kubota Recalls Riding Mowers Due to Fire Hazard (Recall Alert)

May 21, 2013 Kubota Manufacturing of America Corp., of Gainesville, Ga. About 8,600 units

CPSC Ongoing

Lea Industries Recalls Children’s Beds Due to Fall Hazard

May 21, 2013 About 59,200 in the U.S. and 4,200 in Canada units

FDA Food Class II Terminated

BIG COUNTRY BREAKFAST, CASE WEIGHT 26 LBS., MANUFACTURED BY: FOOD CONCEPTS, LEBANON, TN 37087

May 21, 2013 Food Concepts 43 cases units

FDA Drug Class II Terminated

Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18); c) 2B1306- 50 mL in Viaflex S

May 21, 2013 Baxter Healthcare Corp. 1,788,292 units units

FDA Drug Class II Terminated

Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48

May 21, 2013 Baxter Healthcare Corp. 172,296 units units

FDA Drug Class II Terminated

0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015

May 21, 2013 Baxter Healthcare Corp. 845,520 units units

FDA Food Class II Terminated

IMAGIC Vegetarian Burger Mix, VB 100, textured vegetable protein, contains soy and wheat, packaged in 25-lb/bulk cartons. CHS Inc., Hutchinson, KS.

May 21, 2013 C H S Inc 173/25-lb cartons units

FDA Food Class II Terminated

RAGIN' CAJUN, WEIGHT 32 LBS, MANUFACTURED BY: FOOD CONCEPTS, LEBANON, TN 37087

May 21, 2013 Food Concepts 76 cases units

FDA Food Class II Terminated

SPANISH SENSATION, NET WEIGHT 32 LBS, MANUFACTURED BY: FOOD CONCEPTS, LEBANON, TN 37087

May 21, 2013 Food Concepts 29 cases units

FDA Drug Class II Terminated

5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015

May 21, 2013 Baxter Healthcare Corp. 730,848 units units

NHTSA Ongoing

Trailer Brake Actuator may Fail

May 21, 2013 ELITE TRAILER MANUFACTURING, LLC 3 units

FDA Drug Class III Terminated

Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11

May 21, 2013 Fresenius Kabi USA, LLC 80,480 vials units

FDA Drug Class II Terminated

Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per

May 21, 2013 Sun Pharmaceutical Industries Inc. 46387 Cartons units