Product Recalls in 2015

FDA Drug Class I Terminated

fentaNYL CITRATE 4 MCG/mL in 0.9% SODIUM CHLORIDE Injection, in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993491

August 21, 2015 Cantrell Drug Company 148 syringes units

FDA Drug Class II Terminated

Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution, packaged in 30x3 mL Sterile Unit-Dose Vials, a) 30 count (NDC 0487-0201-03) and b) 60 count (NDC 0487-0201-60) vials per cart

August 21, 2015 Nephron Pharmaceuticals Corp. a) 85,248 cartons and b) 35,292 cartons units

NHTSA Ongoing

Trailer Suspension Pivot Bolt Failure

August 21, 2015 Strick Trailers, LLC 4 units

FDA Drug Class I Terminated

fentaNYL Citrate 1 MCG/mL in 0.9% Sodium Chloride Injection, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992131

August 21, 2015 Cantrell Drug Company 42 syringes units

FDA Drug Class I Terminated

fentaNYL Citrate 50 mcg/mL in Sterile Water for Injection, packaged in 2 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-074-16, UPC: 0100352533074165

August 21, 2015 Cantrell Drug Company 1652 syringes units

NHTSA Ongoing

Transit Arm Latch May Loosen

August 21, 2015 McNeilus Truck & Manufacturing, Inc. 809 units

NHTSA Ongoing

Wheel Chair Lift Link Arm Pivot Holes

August 21, 2015 RICON CORPORATION 38,000 units

FDA Drug Class II Terminated

MIDAZOLAM HCl in 0.9% Sodium Chloride Injection, 2 mg/2 mL (1 mg/mL), in 2 mL syringe, Rx only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-001-16 UPC: 0100352533001161

August 21, 2015 Cantrell Drug Company 1570 syringes units

FDA Drug Class II Terminated

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator, Starter Kit (Racepinephrine 11.25 mg) 10 individual foil wrapped vials with 1 EZ Breathe Atomizer per carton, Manufactured By: nephron p

August 21, 2015 Nephron Pharmaceuticals Corp. 47,754 cartons units

FDA Drug Class III Terminated

Lamivudine Oral Solution, USP, 10 mg per 1 mL, 240 mL bottle (8 ounces), Rx only, Manufactured by: Silarx Pharmaceuticals, Inc. Carmel, NY 10512, NDC 54838-0566-70

August 21, 2015 Silarx Pharmaceutical, Inc. 576 bottles units

FDA Drug Class II Terminated

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator Refills (Racepinephrine USP 11.25 mg), 30 individual foil wrapped vials per carton, Manufactured By: nephron pharmaceuticals corporation

August 21, 2015 Nephron Pharmaceuticals Corp. 32,490 cartons units

FDA Drug Class II Terminated

MIDAZolam HCl 0.1 mg/mL in 5% DEXTROSE 2.5 mL syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999993721

August 21, 2015 Cantrell Drug Company 212 syringes units

FDA Drug Class II Terminated

LIDocaine HCl 1% BUFFERED WITH SODIUM BICARBONATE Injection, packaged in 3 mL Syringes, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992033

August 21, 2015 Cantrell Drug Company 450 syringes units

FDA Drug Class I Terminated

fentaNYL citrate in 0.9% Sodium Chloride Injection, 10 mcg/1 mL (10 mcg/mL), in 1 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- NDC 52533-024-45, UPC: 0100352533024450

August 21, 2015 Cantrell Drug Company 884 syringes units

FDA Drug Class II Terminated

HEParin Sodium 0.5 USP UNITS/mL in 0.225% SODIUM CHLORIDE, in 3 mL Syringe, Rx Only, Cantrell Drug Co., Little Rock, AR --- UPC: 9999992212

August 21, 2015 Cantrell Drug Company 352 syringes units

FDA Food Class III Terminated

Coquette's Gluten Free Spring Pack Cupcakes (4 pack), Oranges n' Cream & Strawberry Mint Lemonade. coquettesbistro.com. NET Wt. 9.67 OZ. No expiration date on package, sold in ambient air at retail

August 21, 2015 Coquette's Bistro and Bakery 120 packages units

FDA Drug Class III Terminated

Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10

August 21, 2015 Akorn, Inc. 13,896 bottles units

FDA Drug Class II Terminated

Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --- NDC 52533-157-45, UPC: 0100352533157455

August 21, 2015 Cantrell Drug Company 3853 syringes units

NHTSA Ongoing

Passenger Seat Belt Anchorage/FMVSS 210

August 20, 2015 FORD MOTOR COMPANY 25,941 units

FDA Food Class I Terminated

Salted Smoked Split Herring in bulk wooden boxes, Net Wt. 18 lbs., Product of Canada --- No label provided for bulk product.

August 20, 2015 P East Trading Corporation 17 - 18 lbs. wooden boxes (cartons) units

FDA Food Class I Terminated

Deep All Natural Spices Coriander Powder, Net Wt 400g/14.1 oz Product of India, Distributed by: Chetak New York, L.L.C. Edison, NJ 08837 USA

August 20, 2015 CHETAK NEW YORK LLC 300 - 14.1 ounce plastic containers. units

FDA Food Class II Terminated

The product is in the form of a salad kit. It contains two plastic bags and one plastic container. The contents are; salad 3.7 lbs/bag, arugula 2.5 oz/bag, and a 1.2 lb cup of dressing.

August 20, 2015 Brett Anthony Foods

FDA Drug Class III Terminated

RIFAMPIN FOR INJECTION USP, 600 mg*/vial, Rx Only. Mfd. for: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-151-42.

August 20, 2015 Akorn, Inc. 6861 Vials units

NHTSA Ongoing

Pressure Relief Device may not Vent Pressure

August 20, 2015 OSHKOSH CORPORATION 33 units

NHTSA Ongoing

Ball Joints may Detach from Front Suspension

August 20, 2015 Reyco Granning 2,016 units

FDA Drug Class II Terminated

Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05

August 20, 2015 Hospira, Inc. 83,320 vials units

FDA Food Class I Terminated

Dry Grated Romano, Tipico Item #1-00111000, Net Wt. 50 lbs.

August 20, 2015 Tipico Products Company, Inc. 2,000 pounds units

FDA Food Class I Terminated

Hellmann's Zesty Italian Dressing, One Gallon (128 fl oz) 3.70 L

August 20, 2015 MCF Operating LLC 1,384/2/1 and 1,793/4/1 gallon/containers/cases units

CPSC Ongoing

Madewell Recalls Women's Sandals Due to Fall Hazard

August 20, 2015 About 50,600 (in addition about 300 were sold in Canada) units

FDA Drug Class II Terminated

Midazolam (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 665 units

FDA Drug Class II Terminated

Ketamine 100 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 600 units

FDA Drug Class II Terminated

Phenylephrine (PF) 100 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 500 mcg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals N/A units

FDA Drug Class II Terminated

Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 25 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 4123 units

FDA Drug Class II Terminated

Morphine Sulfate (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 475 units

FDA Drug Class II Terminated

Ketamine 50 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 250 units

FDA Drug Class II Terminated

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.0625 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals N/A units

FDA Drug Class II Terminated

Morphine Sulfate (PF) 0.1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.1 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 525 units

FDA Drug Class II Terminated

Fentanyl Citrate (PF) 50 mcg/mL, injectable packed in syringes a) Total dosage 250 mcg/ 5mL, b) Total dosage 100 mcg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 7100 units

FDA Drug Class II Terminated

Ondansetron 2 mg/mL, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 4100 units

FDA Drug Class II Terminated

Rocuronium 10 mg/mL, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 5875 units

FDA Drug Class II Terminated

Midazolam (PF) 0.5 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 0.5 mg/ 1mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 210 units

FDA Drug Class II Terminated

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 16 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 378 units

FDA Drug Class II Terminated

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 4 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals N/A units

FDA Drug Class II Terminated

Succinylcholine 20 mg/mL, injectable packed in syringes, Total dosage 100 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 2750 units

NHTSA Ongoing

Dinette Convertible may Slide Out of Position

August 19, 2015 THOR MOTOR COACH 98 units

NHTSA Ongoing

Unable to Select Defrost Mode

August 19, 2015 THOR MOTOR COACH 290 units

FDA Drug Class II Terminated

Glycopyrrolate 0.2 mg/mL, injectable packed in syringes, Total dosage 1 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 1530 units

FDA Drug Class II Terminated

Epinephrine (PF) 10 mcg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 50 mg/ 5mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 1150 units

FDA Drug Class II Terminated

Provocholine Pre-diluted Set II in 0.9% Sodium Chloride, 0.25 mg/mL, 3 mL in 5 mL Syr, injectable packed in syringes, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals N/A units

FDA Drug Class II Terminated

Midazolam 1 mg/mL in 0.9% Sodium Chloride, injectable packed in syringes, Total dosage 2 mg/ 2mL, Rx only, PHARMAKON Pharmaceuticals, Inc.

August 19, 2015 Pharmakon Pharmaceuticals 5000 units