Product Recalls in 2013

FDA Drug Class II Terminated

VANCOMYCIN HCL 10 mg/mL OPHTHALMIC SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 50 mL units

FDA Drug Class II Terminated

TESTOS CYPIONATE* IN OLIVE OIL 200 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 17.5 ml units

FDA Drug Class II Terminated

WB-Tranexamic acid, 2 g/Placebo 100 mL, DRUG STUDY, packaged as a) 100 mL INJECTABLE, b) TOPICAL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy a) 1900 injectable; b) 1900 mL topical units

FDA Drug Class II Terminated

CYCLOPENTOLATE HCL* (FOR COMPOUNDING) 2% OPHTHALMIC, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 5 mL units

FDA Drug Class II Terminated

EPINEPHRINE PF SF* (0.3 mL); (1 mL), (0.5 mL IN 3 mL SYRINGE) 1:1000 OPHTH SOL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 157.08 mL units

FDA Drug Class II Terminated

FLUCON/GENT* (fluconazole and gentamicin) 200 mg/480 mg/1 L SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 700 mL units

FDA Drug Class II Terminated

Ceftazidime, 22.5 mg/ml (ophthalmic), Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 44.44 mL units

FDA Drug Class II Terminated

Aluminum Potassium Sulfate Sterile powder, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 160 grams units

FDA Drug Class II Terminated

Cyanocobalamin, 1000 mcg/ml; injectable, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 180 mL units

FDA Drug Class II Terminated

TRIPLE MIX* 15 mg/1 mg/20 mcg/mL INJECTABLE, TRIPLE MIX* 30 mg/1 mg/20 mcg/mL INJECTABLE (papaverine hydrochloride, phentolamine, prostaglandin), Rx only, Specialty Medicine Compounding Pharmacy, 350

October 19, 2013 Specialty Medicine Compounding Pharmacy 44 mL units

FDA Drug Class II Terminated

TRANEXAMIC ACID* 2 g/75 mL SOLUTION, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 3000 mL units

FDA Drug Class II Terminated

Magnesium Sulfate, 1 gm/50 mL; 2 gm/50 mL, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 19200 mL units

FDA Drug Class II Terminated

DEXAMETHASONE NAPO4* PF 4MG/ML SOLUTION, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 70 mL units

FDA Drug Class II Terminated

SODIUM PHOSPHATE* PF 3MMOL/mL INJECTABLE, SODIUM PHOSPHATE* PF(15 mL) 3MMOL/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 9200 mL units

FDA Drug Class II Terminated

POTASSIUM PHOSPHATE* PF 4.4 MEQ (3MM)/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 600 mL units

FDA Drug Class II Terminated

Glutathione PF, 60 mg/mL inhalation, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 126 mL units

FDA Drug Class II Terminated

FLUOROURACIL* PF 50 mg/mL INJECTABLE, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 4.4 mL units

FDA Drug Class II Terminated

Neomycin Sulfate* ophthalmic solution, 333 mg/mL, all sizes, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178

October 19, 2013 Specialty Medicine Compounding Pharmacy 5582.6 mL units

FDA Drug Class II Terminated

Quad Mix Injectable, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.

October 18, 2013 Compounding Centre At Blue Ridge 1 unit units

FDA Food Class II Terminated

Organic Parsley Chive Chevre sold to non-restaurant in plastic 6 oz plastic tub vacuum-sealed with lid and label on top of tub, Sunny Pine Farm brand. Product sold to restaurant is in 1 lb. and 2 l

October 18, 2013 Sunny Pine Farm 200/6 oz. tubs; 1/1 lb. package; 2/2 lbs. packages units

FDA Food Class II Terminated

NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 900 g (31.7 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 949682 801748; Manufactured by: S&M(HK) ENTERPRISE LTD. RM3.8/F.,

October 18, 2013 Lsg Food World Inc exact quantity cannot be determined units

NHTSA Ongoing

Interior Side Door Lock May Become Inoperable

October 18, 2013 AMERICAN HAULER 1,103 units

FDA Food Class II Terminated

NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 912 g (32 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 949682 801731. *1st label indicates: Manufactured by: JINYYIFAN(HK

October 18, 2013 Lsg Food World Inc 3068 cartons at a minimum units

FDA Food Class II Terminated

NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 900 g (31.7 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 949682 801755; Manufactured by: S&M(HK) ENTERPRISE LTD. RM3.8/F.,

October 18, 2013 Lsg Food World Inc exact quantity cannot be determined units

FDA Drug Class I Terminated

Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30.

October 18, 2013 Hospira, Inc. 40,360 vials units

FDA Drug Class II Terminated

Super Triple Mix Injectable, (aka Dr Lentz Triple Rx Injectable; Dr Kane's Super Triple Rx Injectable; Dr Tortora's Super Triple Rx Injectable), 5 mL vial, Rx Only, The Compounding Center at Blue Ridg

October 18, 2013 Compounding Centre At Blue Ridge 3 Vials units

FDA Food Class II Terminated

NOODLES HOUSE HOME STYLE NOODLES, Net Wt. 912 g (32 oz), product is packaged in plastic bag with twelve (12) bags per carton. UPC 6 949682 801724; *1st label indicates: Manufactured by: JINYYIFAN(HK

October 18, 2013 Lsg Food World Inc 1025 cartons at a minimum units

NHTSA Ongoing

Increased Stopping Distance when using ABS

October 18, 2013 NISSAN NORTH AMERICA, INC. 151,695 units

FDA Food Class II Terminated

Organic Black Pepper Garlic Chevre is sold in 3 lbs. vacuum plastic bag without labels since it sold to restaurants. However, the retail label is read in parts: "***Organic Goat Dairy***Black Peppe

October 18, 2013 Sunny Pine Farm 5/3 lbs. packages units

FDA Food Class II Terminated

Organic Honey Lavender Chevre is sold in plastic 6 oz tubs under Sunny Pine Farm brand. The product is labeled in parts: "***Organic Goat Dairy***Honey Lavender Chevre***6 oz.***SUNNY PINE FARM***H

October 18, 2013 Sunny Pine Farm 206/6 oz. tubs. units

FDA Food Class II Terminated

Organic Chevre sold at Farmer's Market in plastic 6 oz tubs, vacuum-sealed with lid and label on top of tub, Sunny Pine Farm brand. Product also sold to in 2 lbs. and 3 lbs. to restaurant. Produ

October 18, 2013 Sunny Pine Farm 121/6 oz. packages.; 2/2 lbs. packages; 11/3 lbs. packages units

FDA Food Class II Terminated

1) 8" Coconut Custard Pie, Net Wt 22 oz (1 lb 6oz), UPC numbers 4173523721 and 4173522453, 2) 10" Coconut Custard Pie, Net Wt 42 oz (2 lb 10oz), UPC number 4173523713

October 18, 2013 Price Chopper Supermarkets 36 pies sold to customers (2 pies were quarantined in store) units

NHTSA Ongoing

Interior Side Door Lock May Become Inoperable

October 18, 2013 Bloomer Trailers 154 units

FDA Drug Class II Terminated

Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.

October 18, 2013 Compounding Centre At Blue Ridge

NHTSA Ongoing

Clutch Master Cylinder Failure

October 18, 2013 MITSUBISHI MOTORS NORTH AMERICA, INC. 10,474 units

FDA Drug Class II Terminated

Triple Mix Injectable (aka Dr Ungers Triple Rx; Dr Tortora's Triple Rx; Dr Bennett's Triple Rx; Dr Neighbors Triple Rx Injectable; Dr Leatherman's Triple Rx Injectable; Dr Kane's Triple Rx Injectable

October 18, 2013 Compounding Centre At Blue Ridge 92 units units

FDA Drug Class II Terminated

PGE 20 mcg/mL Injectable, 10 mL, and PGE 40 mcg/mL, 5 mL, Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.

October 18, 2013 Compounding Centre At Blue Ridge 11 units units

NHTSA Ongoing

Trailer May Release from Fifth Wheel

October 17, 2013 NAVISTAR, INC 16,107 units

NHTSA Ongoing

Interior Side Door Lock May Become Inoperable

October 17, 2013 Craftsmen Industries, Inc. 79 units

NHTSA Ongoing

Clogged A/C Drain may cause Air Bags to Deploy

October 17, 2013 Toyota Motor Engineering & Manufacturing 802,769 units

FDA Food Class I Terminated

Pran Spice Powder Turmeric , 14.10 oz. (400g) clear plastic laminated pouch, UPC 8 3173000502 3

October 17, 2013 Fahman Enterprises, Inc 4 cases units

FDA Food Class II Terminated

Digestive Enzyme Complex/Enzyme Formula Caps, Quantity:13M, Product #: IB286, product is packaged in bulk form. Manufactured For: Indiana Botanic. Manufactured by Nature's Value Inc. 468 Mill Road,

October 17, 2013 Nature's Value Inc. 796,800 total capsules for all varieties units

NHTSA Ongoing

Lower Control Arms May Fracture

October 17, 2013 SPARTAN MOTORS, INC. 75 units

FDA Food Class II Terminated

Vitacost Mega Spectrum Enzyme, packaged with 180 Vegetarian Capsules, UPC Code: 84419701519. Manufactured for Vitacost Lexington, NC 27295

October 17, 2013 Nature's Value Inc. 796,800 total capsules for all varieties units

NHTSA Ongoing

Seat Impact Resistance/FMVSS 222

October 17, 2013 Lion Bus Inc. 1 units

FDA Food Class II Terminated

Vitacost Super Daily Enzymes 500 mg caps, product is packaged in a plastic bottle with 240 capsules per bottle, UPC Code: 844197017164. Manufactured for Vitacost Lexington, NC 27295.

October 17, 2013 Nature's Value Inc. 796,800 total capsules for all varieties units

FDA Food Class I Terminated

KCB Pista Khatie KCB Bakery Products Corp. 56-28 56th Street, Maspeth, NY 11378 Tel: (718) 786-9463 Fax (718) 361-0171 www.kbcusa.com a) Net Wt. 30 OZ (850 G) b) Net Wt. 13 OZ (369 G) Pac

October 17, 2013 Kashmir Crown Baking LLC 24 cases x 12 plastic clam shell boxes; 15 cases x 13 clam shel boxes units

FDA Drug Class III Terminated

Ciclopirox Shampoo 1%, Net Wt. 120 mL. bottles, Rx only. Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1. Dist. by: TARO Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532. NDC 5

October 16, 2013 Taro Pharmaceuticals U.S.A., Inc. 850 bottles units

FDA Drug Class II Terminated

Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50

October 15, 2013 VistaPharm, Inc. 27,788 cases units

FDA Drug Class I Terminated

Cefepime for Injection USP and Dextrose Injection USP, in Duplex Drug Delivery System, 1 g in 50 mL duplex container, For IV Use Only, Single Dose, Sterile/Non pyrogenic, Rx Only, B Braun Medical Inc.

October 15, 2013 B. Braun Medical Inc 18,936 Containers units