Product Recalls in 2016

FDA Food Class II Terminated

Lite Creamy Alfredo, gluten free, Pasta Sauce; Glass jar, metal lid; NET WT. 15 OZ, CONT. NET 425g; UPC 41220898732

December 16, 2016 Berner Food & Beverage, LLC 1,224 cases units

FDA Food Class II Terminated

Tipiak Pearled Couscous Easy cooking 12.3 Oz (350g) Item Number: 10020450803 Product of France

December 16, 2016 TIPIAK Inc 27 cases ( 8 boxes/case) units

FDA Food Class II Terminated

Creamy Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 41220845941, 70038626695 or 041498172855

December 16, 2016 Berner Food & Beverage, LLC 1,149 cases units

FDA Food Class I Terminated

Boston Choc/Fudge Iced packaged on plastic trays with domed lids.

December 16, 2016 HEB Retail Support Center 1214 units units

FDA Food Class I Terminated

Fresh Strawberry Boston - FRZ and Fresh Strawberry Boston Cake packaged on plastic trays with domed lids.

December 16, 2016 HEB Retail Support Center 190 units units

FDA Food Class II Terminated

TR-MEXICALI SAUCE SEASONING NET WEIGHT: 50.00 LBS

December 16, 2016 Chesapeake Spice Company, LLC 1300 units

FDA Food Class II Terminated

Our Family Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 70253266867

December 16, 2016 Berner Food & Beverage, LLC 204 cases units

FDA Food Class I Terminated

Boston with Fresh Fruit packaged on plastic trays with domed lids.

December 16, 2016 HEB Retail Support Center 130 units units

FDA Drug Class III Terminated

Pantoprazole Sodium for Injection, 40mg per vial, Single-dose vial, Rx only, Mfd. in India for: Auromedics Pharma LLC 6 Wheeling Road, Dayton, NJ 08810, NDC 55150-202-00

December 16, 2016 Aurobindo Pharma USA Inc 29800 vials units

FDA Drug Class II Terminated

MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- NDC 63323-412-05

December 16, 2016 Fresenius Kabi USA, LLC 47, 020 vials units

FDA Food Class II Terminated

Four Cheese Alfredo, Pasta Sauce; NET WT. 15 OZ, CONT. NET 425g; Glass jar, metal lid; UPC 70038627838, 36800334793 or 041498198084

December 16, 2016 Berner Food & Beverage, LLC 850 cases units

NHTSA Ongoing

Seat Mounted Air Bag Non-Deployment

December 16, 2016 Chrysler (FCA US LLC) 25 units

NHTSA Ongoing

Improper Intiator Generant Mix Ratio

December 16, 2016 AUTOLIV, INC. 116,820 units

NHTSA Ongoing

Rear Door Hinge Weld may be Insufficient

December 16, 2016 KEYSTONE RV COMPANY 1,608 units

NHTSA Ongoing

Missing Information on Label/FMVSS 110, 567

December 16, 2016 C & M Trailers Inc. 2,605 units

NHTSA Ongoing

Air Bag Fasteners May Loosen Affecting Deployment

December 16, 2016 Toyota Motor Engineering & Manufacturing 12 units

NHTSA Ongoing

Crankshaft Sensor May Fail Causing Engine Stall

December 16, 2016 Chrysler (FCA US LLC) 42,231 units

CPSC Ongoing

Craftsman Brand Chainsaws Recalled by MTD Southwest Due to Fire Hazard

December 15, 2016 Zhejiang Pioneer Machinery & Electron Co., Ltd., of China About 19,500 units

CPSC Ongoing

Figi's Companies Recalls "Christmas Wishes" Tins Due to Choking and Button Battery Ingestion Hazard (Recall Alert)

December 15, 2016 Figi's Companies Inc., of Marshfield, Wis. About 5,000 units

CPSC Ongoing

Remington Brand Chainsaws Recalled by MTD Southwest Due to Fire Hazard

December 15, 2016 Zhejiang Pioneer Machinery & Electron Co., Ltd., of China About 8,000 units

FDA Food Class III Terminated

Starkey Spring Water, Item code STC.5, 16.9 FL oz. (500 mL) glass bottle. Product UPC 8 11904 02000 7. Case UPC 8 11904 02002 1.

December 15, 2016 Starkey Water 2030 cases (15 bottles per case) units

FDA Drug Class II Terminated

AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused portion, For Intravenous Administration Only, Rx Only, Manufactured for: Onyx Pharmaceuticals, Inc., Thousand Oaks, CA 91320

December 15, 2016 Amgen, Inc. 11,434 vials units

FDA Drug Class II Terminated

Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bottles, Meta Pharmacy Services. NDC 99999-0106-99 Sterile compounded drug, Hospital/office use only, Not for resale Stora

December 15, 2016 Meta Pharmacy Services 150 mL units

FDA Drug Class II Terminated

Gentell Hydrogel Wound Dressing REGULAR, 4 oz. tube, Manufactured by: Gentell, 2701 Bristol, PA 19007, NDC 61554-111-04

December 15, 2016 Gentell, Inc unknown units

FDA Drug Class II Terminated

Gentell Hydrogel Ag Saturated Gauze, 2"x2"(NDC 61551-112-20), 4x4(NDC 61554-114-24) and 4"x8"(NDC 61554-118-28), Manufactured by: Gentell, 2701 Bartram Road, Bristol, PA 19007

December 15, 2016 Gentell, Inc 3,000 gauzes units

FDA Food Class I Terminated

LIZARD FISH (Eviscerated), 15 KGS, PRODUCT OF VIETNAM --- DISTRIBUTED BY ARCADIA TRADING INC. BROOKLYN, NY 11211

December 15, 2016 Arcadia Trading Inc. 34 x 15 kgs cartons units

NHTSA Ongoing

Classification System may Deactivate Air Bag

December 15, 2016 MERCEDES-BENZ USA, LLC. 47,799 units

NHTSA Ongoing

Entrance/Exit Steps may Unexpectedly Retract

December 15, 2016 JAYCO, INC. 680 units

NHTSA Ongoing

Cot May Not Be Securely Fastened

December 15, 2016 Halcore Group, Inc. 7 units

NHTSA Ongoing

Seatbelt Component may Detach and Enter the Cabin

December 15, 2016 AUTOLIV, INC. 111,500 units

CPSC Ongoing

Trek Recalls Bicycle Lights Due to Injury Hazard

December 14, 2016 About 600 units

FDA Food Class I Terminated

Old Dutch Ripples French Onion flavored Potato Chips, 2 oz., UPC 74690-023670, and 8 oz. UPC 74690-230160.

December 14, 2016 Old Dutch Foods, Inc 505,705 units units

FDA Food Class II Terminated

Whole Wheat Bread, each loaf has a net wt. 32 oz.. The UPC is code 6 36428 50200 2.

December 14, 2016 Great Northern Bakehouse Inc. dba Le Petit Outre 103 units units

FDA Food Class I Terminated

Urge Ranch flavored Tortilla Chips, 8 oz., UPC 39779-013126.

December 14, 2016 Old Dutch Foods, Inc 127,120 units units

FDA Food Class I Terminated

Cheddar & Sour Cream flavored Potato Chips packaged under the following brands and sizes: 1. Old Dutch Ripples, 2 oz, UPC 74690-024066; 8 oz., UPC 74690-230290; and 15.5 oz., UPC 74690-205694.

December 14, 2016 Old Dutch Foods, Inc 1,775,790 units units

FDA Food Class I Terminated

SunRidge Farms Women's Vitality Mix Bulk PLU#70610 and retail units packaged in a clear plastic tub.

December 14, 2016 HEB Retail Support Center 12,927 pounds units

FDA Food Class II Terminated

Brewers Grain Deli Loaf, each loaf has a net wt. 24 oz.. The UPC code is 6 36428 10300 1.

December 14, 2016 Great Northern Bakehouse Inc. dba Le Petit Outre 55 units units

FDA Food Class II Terminated

Birdman Bread, each loaf has net wt. 24 oz and 32 oz.. The UPC code ia 6 36428 10200 4.

December 14, 2016 Great Northern Bakehouse Inc. dba Le Petit Outre 417 units total units

FDA Food Class I Terminated

SunRidge Farms Dark Chocolate Pistachios Bulk PLU# 70289 and retail units packaged in clear plastic tub.

December 14, 2016 HEB Retail Support Center 395 pounds units

FDA Drug Class II Terminated

Torsemide Tablets, 5 mg 100-count bottle, Rx only ,Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0232-01

December 14, 2016 Apotex Corp. 13,179 bottles (1,317,900 tablets) units

FDA Food Class II Terminated

Italian Deli Loaf, each loaf has a net wt. 32 oz.. The UPC is code 6 36428 50200 2.

December 14, 2016 Great Northern Bakehouse Inc. dba Le Petit Outre 72 units units

FDA Food Class I Terminated

Delizza Patisserie, Belgian Custard Cream Mini Eclairs, Net Wt. 420g  14.8 oz., UPC Code: 6 76670 00106 9(30 count) and Net Wt. 700g  24.6 oz., UPC Code: 6 76670 00105 2 (50 count).

December 14, 2016 Poppie International INC 147,268 cases (6 units per case) units

FDA Food Class II Terminated

Sourdough Deli Loaf, each loaf has a net wt. 28 oz.. The UPC is code 6 36428 50200 2

December 14, 2016 Great Northern Bakehouse Inc. dba Le Petit Outre 165 units units

FDA Food Class I Terminated

Jalapeno Popper flavored Potato Chips packaged under the following brands and sizes: 1. Old Dutch Ripples, 3 oz, UPC 74690-028590; and 8 oz., UPC 74690-231556. 2. Roundy's, 10.5 oz, UPC 11150

December 14, 2016 Old Dutch Foods, Inc 90,883 units units

FDA Food Class I Terminated

Poppies Belgian Eclairs,Net Wt. 710 g/25 oz., Contents 50 ct. Mini Eclairs, UPC Code: 0 08563 10710 5.

December 14, 2016 Poppie International INC

FDA Food Class I Terminated

Delizza Patisserie, Beligian Mini Chocolate Dipped Cream Puffs, Net Wt. 400g  14.1 oz. (30 count), UPC Code: 6 76670 00402 2.

December 14, 2016 Poppie International INC

FDA Food Class II Terminated

Daily Wheat Bread, each loaf has a net wt. 24 oz.. The UPC is code and 6 36428 50500 3.

December 14, 2016 Great Northern Bakehouse Inc. dba Le Petit Outre 24 units units

FDA Food Class I Terminated

Cranberry Orange Scone, brand Mad Batter Bakery, net wt. 5 oz per unit. Product is sold in a plastic film wrapper with labeling on the back of the package.

December 14, 2016 Thomas Hammer Coffee Roasters, Inc. 52/ 5 oz. units units

FDA Drug Class II Terminated

Torsemide Tablets, 20 mg 100-count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9W, 6Y3, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0234-01

December 14, 2016 Apotex Corp. 35,819 bottles (358,190,000 tablets) units

FDA Drug Class III Terminated

Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spray), packaged in 30 mL bottles, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-0293

December 14, 2016 Roxane Laboratories, Inc. 74,108 bottles units