Product Recalls in 2016

FDA Drug Class II Terminated

USCG Boat Response Kit - Product Code 80-0353, North American Rescue

September 27, 2016 North American Rescue LLC. unknown units

FDA Drug Class III Completed

Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in

September 27, 2016 Par Pharmaceutical Inc. 278,406 tablets units

FDA Drug Class II Terminated

Range Trauma Kit ORG - Product Code 80-0213, 80-0299, 80-0298, North American Rescue

September 27, 2016 North American Rescue LLC. unknown units

FDA Drug Class II Terminated

Amphibious Trauma Kit - Product Code 85-0639, North American Rescue

September 27, 2016 North American Rescue LLC. unknown units

FDA Drug Class II Terminated

Range Trauma Kit - Product Code 85-1274, North American Rescue

September 27, 2016 North American Rescue LLC. unknown units

NHTSA Ongoing

Panoramic Roof Panel may Separate from Vehicle

September 27, 2016 FORD MOTOR COMPANY 887 units

FDA Drug Class II Terminated

Mini Resupply Trauma Kit - Product Code 85-0835, North American Rescue

September 27, 2016 North American Rescue LLC. unknown units

FDA Food Class I Terminated

ATLANTIC Smoked SALMON Whole, Net Wt. 8 OZ (225.89), Keep Refrigerated 38¿F or Below

September 26, 2016 K & P Marketplace Ltd. d.b.a Mt. Kisco Smokehouse Ltd. 158 units units

NHTSA Ongoing

Front Brake Master Cylinder may Let in Air

September 26, 2016 Piaggio Group Americas. Inc. 1,628 units

FDA Food Class II Terminated

GoPicnic Turkey Slices & Cheddar Cheese; 4 Individually Packed Snacks; GLUTEN FREE; Best by: 31 JAN 2017

September 26, 2016 SSI-GoPicnic LLC 1,584 individual cartons units

NHTSA Ongoing

Engine Stalling Due to ECU Software

September 26, 2016 BMW OF NORTH AMERICA, LLC 1,398 units

FDA Food Class I Terminated

Sliced - Smoked ATLANTIC SALMON, Net Wt. 8 OZ (225.89), Keep Refrigerated 38¿F or Below

September 26, 2016 K & P Marketplace Ltd. d.b.a Mt. Kisco Smokehouse Ltd. 952 units units

NHTSA Ongoing

Insufficient Strength of Roller Chain on Lift Gate

September 26, 2016 FOREST RIVER, INC. 45 units

NHTSA Ongoing

Incorrect Weight Capacity on Tow Hitch Sticker

September 26, 2016 TIFFIN MOTORHOMES, INC. 1,658 units

NHTSA Ongoing

A/C Water Drain may Affect Air Bag Deployment

September 26, 2016 Volvo Car USA LLC 43,766 units

FDA Food Class II Terminated

Central Market, Tortilla Chips, Veggie & Seed Blend, Net Wt.; 12oz (340g), Distributed by H.E.B Central Markets, Austin, TX 78735.

September 25, 2016 R.W.Garcia Co., Inc. 848 cases units

FDA Food Class II Terminated

RW Garcia, 3 Seed, Sweet Potato Crackers, (Flaxseed, Sesame & Chia), Gluten Free, Net Wt., 30 oz., Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., San Jose, CA 95112 and Lincolnto

September 25, 2016 R.W.Garcia Co., Inc. 9760 cases units

FDA Food Class II Terminated

Trader Joes, Veggie Flaxseed Tortilla Chips, Net Wt. 12oz. (340g), Distributed and Sold by Trader Joes, Monrovia, CA 91014.

September 25, 2016 R.W.Garcia Co., Inc. 3228 cases units

FDA Food Class II Terminated

365, Lightly Salted Tortilla Chips, Multigrain, Net Wt. 16oz. (1 lb.) 454g, Distributed by Whole Foods Market, Austin, TX 78703.

September 25, 2016 R.W.Garcia Co., Inc. 143 cases units

FDA Food Class II Terminated

RW Garcia, 3 Seed.Graines, Kale Crackers, Craquelins de Kale, Gluten Free, Net Wt. 180g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., Las Vegas, NV 89115 and Lincoln, NC 28092,

September 25, 2016 R.W.Garcia Co., Inc. 200 cases units

FDA Food Class II Terminated

365, White Corn, Tortilla Chips, Unsalted, Net Wt. 16 oz. (1 lb.) 454g., Distributed by Whole Foods Market, Austin, TX 78703.

September 25, 2016 R.W.Garcia Co., Inc. 425 cases units

FDA Food Class II Terminated

365, White Corn, Tortilla Chips, Lightly Salted, Net Wt. 16 oz. (1 lb.) 454g., Distributed by Whole Foods Market, Austin, TX 78703.

September 25, 2016 R.W.Garcia Co., Inc. 776 cases units

FDA Food Class II Terminated

RW Garcia, 3 Seed, Kale Crackers, Gluten Free, Net Wt. 180g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., Las Vegas, NV 89115 and Lincoln, NC 28092, Distributed by Clean Foods,

September 25, 2016 R.W.Garcia Co., Inc. 49 cases units

FDA Food Class II Terminated

RW Garcia, 3 Seed, Sweet Potato Crackers, (Flaxseed, Black & White sesame Seeds), Gluten Free, Net Wt., 180g and 850g, Product of USA, Manufactured & Distributed by R.W. Garcia Co., Inc., San Jose, CA

September 25, 2016 R.W.Garcia Co., Inc. 4700 cases units

FDA Food Class II Terminated

Harris Teeter, Multigrain, Tortilla Chips, Net Wt. 12 oz. (340g), Produced by Harris Teeter, Mathews, NC 28105.

September 25, 2016 R.W.Garcia Co., Inc. 72 cases units

FDA Food Class III Terminated

Label reads in part "*** Bob's Red Mill *** PREMIUM GUAR GUM SUPERB GLUTEN FREE THICKENER & BINDER *** NET WT 8 OZ ***" Product is packaged in multilayered flexible film with multiple colors. Firm

September 24, 2016 Bob's Red Mill Natural Foods, Inc. 443 cs units

NHTSA Ongoing

Tiller Frame may Crack

September 23, 2016 Spartan Motors USA 9 units

NHTSA Ongoing

Tow Hook Bracket May Be Loose

September 23, 2016 Chrysler (FCA US LLC) 100 units

NHTSA Ongoing

Weld of Fuel Tank Recirculation Pipe may Leak

September 23, 2016 MAZDA NORTH AMERICAN OPERATIONS 3,849 units

FDA Food Class II Terminated

Baptista Bakery & Pastry Inc. Torpedo Rolls, 16 oz. plastic

September 23, 2016 Batista Bakery & Pastries, Inc. 30 units units

FDA Food Class II Terminated

Baptista Bakery & Pastry Inc. Portugese Sliced Bread, 16 oz. plastic

September 23, 2016 Batista Bakery & Pastries, Inc. 30 units units

FDA Food Class I Terminated

Allens East Texas Fair Brand, Tiny Tender Field Peas with snaps; NET.WT. 6 lbs. 15 oz.. (3.15kg) UPC 0 34700 623214 8 Distributed by Sager Creek Vegetable Company, Siloam Springs, AR 72761-0250

September 23, 2016 Del Monte Research Center - Walnut Creek 15, 859 cases (6 cans per case) total, all varieties units

FDA Food Class II Terminated

On the Border Blue Corn Tortilla Chips 7.25 oz. and 10 oz. packaged in laminated polypropylene film with windows.

September 23, 2016 Truco Enterprises, Inc 11,753 cases units

FDA Food Class II Terminated

Monocal, Calcium & Fluoride Supplement, 100 Tablets; Mericon Industries, Inc., Peoria, Illinois 61615; UPC: 0394-0105-02

September 23, 2016 Mericon Industries Inc. 158 bottles units

FDA Food Class II Terminated

On the Border Cafe Style Tortilla Chips 18 oz. and 28 oz. packaged in laminated polypropylene film with windows.

September 23, 2016 Truco Enterprises, Inc 48,808 cases units

FDA Drug Class I Terminated

Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-filled syringe, Rx only

September 23, 2016 Guardian Pharmacy Services 180 syringes units

FDA Food Class II Terminated

Baptista Bakery & Pastry Inc. Italian Bread, 16 oz. plastic

September 23, 2016 Batista Bakery & Pastries, Inc. 30 units units

FDA Food Class I Terminated

Cut Green Beans packed under brand names of: Allens Cut Green Beans (Ejotes Cortados Lago Azul) Blue Lake . Allens Cracker Barrel Label (Both labels have same UPC # - different sodium content - 1

September 23, 2016 Del Monte Research Center - Walnut Creek 15, 859 cases (6 cans per case) total, all varieties units

FDA Food Class II Terminated

Baptista Bakery & Pastry Inc. Bulkie Rolls, 16 oz. plastic

September 23, 2016 Batista Bakery & Pastries, Inc. 30 units units

FDA Food Class I Terminated

Frozen Onion Rings sold and distributed under the following private label retail brands: 1) Premium Pick 5 Mix and Match Onion Rings, NET WT 40 OZ, packaged in plastic bags; 2) Krasdale Onion Rings

September 23, 2016 McCain Foods USA 1) 29,956 cases; 2) 1,318 cases; 3) 5,087 cases; 4) 4,313 cases; 5) 16,440 cases; 6) 2,200 cases units

NHTSA Ongoing

Missing Bolt may Allow Seat Belt Webbing to Detach

September 23, 2016 GENERAL MOTORS LLC 131 units

FDA Drug Class III Terminated

PARICALCITOL Capsules, 2 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA

September 22, 2016 Teva Pharmaceuticals USA 5,556 bottles units

FDA Food Class I Terminated

BIKAJI Chowpati BHELPURI, NET WT : 300 g [ 10.58 OZ ], Item No: B022, PRODUCT OF INDIA

September 22, 2016 KRISHNA FOOD CORP 16 cartons units

NHTSA Ongoing

Possible Fuel Leak from Deformed Fuel Tank

September 22, 2016 MAZDA NORTH AMERICAN OPERATIONS 17,484 units

FDA Food Class II Terminated

Tortilla Chip 2 White Corn Masa Flour 50 lb bags

September 22, 2016 Azteca Milling LP 37,500 LBS units

FDA Food Class II Terminated

Tortilla Chip #8 Especial White NGMO Corn Masa Flour 50 lb bags

September 22, 2016 Azteca Milling LP 243,708 LBS units

FDA Drug Class III Terminated

PARICALCITOL Capsules, 4 mcg, 30-count bottles, Rx only, Manufactured By: Pharmaceutics International, Inc., Hunt Vallet, MD 21031; Manufactured For: Teva Pharmaceuticals USA, Inc., North Wales, PA

September 22, 2016 Teva Pharmaceuticals USA 5,398 bottles units

FDA Food Class II Terminated

Truco 1 50/50 Corn Masa Flour 50 lb bags & totes

September 22, 2016 Azteca Milling LP 491,875 LBS units

FDA Food Class II Terminated

Taco 4 Blue Corn Masa Flour 50 lb bags

September 22, 2016 Azteca Milling LP 46,350 LBS units

FDA Food Class II Terminated

Cookies Bergen, Soft Baked Chocolate Brownie Cookies, NET WEIGHT: 4.44 OZ (126g), Produced by P.W. Sponmet Sp.l., Poland

September 22, 2016 Dollar General Corporation 146,455 units units