Product Recalls in 2016

5,616 recalls issued this year

330

CPSC

3,066

FDA Food

1,199

FDA Drug

1,021

NHTSA

FDA Drug Class II Terminated

Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0855-02

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 250 units
FDA Drug Class II Terminated

Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PAB Container); Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0146-47

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 12 units
FDA Food Class I Terminated

Life's Qik Fix 70 Plant Minerals Plus 80 Additional Nutrients 180 Vegetable Capsules Dietary Supplement Manufactured Exclusively For: MAGZUMA NUTRITION Overland Park, Kansas 66210 www.magzuma.com 1-88

April 20, 2016 Liquid Assets Inc 393 bottles units
FDA Drug Class II Terminated

Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0180-72

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 225 units
NHTSA Ongoing

Incorrect Weight Calculations on Label/FMVSS 110

April 20, 2016 GULF STATES TOYOTA, INC. 844 units
FDA Drug Class II Terminated

Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0796-48

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 45 units
FDA Drug Class II Terminated

Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0935-67

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 340 units
CPSC Ongoing

YTL International Recalls Drywall Lifts Due to Injury Hazard

April 20, 2016 About 17,000 (in addition, 2,700 were sold in Canada) units
FDA Drug Class II Terminated

HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0813-68

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 670 units
FDA Drug Class II Terminated

Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 500mL lntravia bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0942-03

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 129 units
FDA Drug Class II Terminated

Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0120-72

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 280 units
FDA Drug Class II Terminated

Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/mL,3 mL; 0.25 mg/mL 3mL; 1 mg/mL 3mL; 4 mg/mL 3mL; 16 mg/ml 3mL, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesvil

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 142 units
FDA Drug Class II Terminated

Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0683-68

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 5 units
FDA Food Class II Terminated

Gourmet Oatmeal Raisin Walnut Cookies, UPC 0007203695193, 4 Ct (Pack 24/4 Ct)

April 20, 2016 Harris Teeter 8487 Units units
FDA Drug Class II Terminated

PEKING NIU-HUANG CHIEH-TU-PIEN Tablets (Sugar Coated), packaged in 50-count bottles within a box, BEIJING TUNG JEN TANG. BEIJING CHINA; remaining labeling contains Chinese characters.

April 20, 2016 Murray International Trading Co., Inc. Unknown units
FDA Drug Class II Terminated

Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0766-03

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 468 units
FDA Food Class II Terminated

12 Count Sugar Cookies, UPC 0007203695601, 12 Ct (Pack 25/12 Ct)

April 20, 2016 Harris Teeter 10571 Units units
FDA Drug Class II Terminated

Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0803-41

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 10 units
FDA Drug Class II Terminated

Norepinephrine Bitartrate 8mg Added to 5% Dextrose 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0806-02

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 70 units
FDA Drug Class II Terminated

Fentanyl Citrate 10 mcg/mL(PF) in 0.9% Sodium Chloride 100 mL fill bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0869-48

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 75 units
FDA Drug Class II Terminated

Oxytocin 10 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0764-03

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 72 units
FDA Drug Class II Terminated

Norepinephrine 16 mg added to 0.9% sodium Chloride, 250 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0174-02

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 24 units
FDA Drug Class II Terminated

Phenylephrine HCI (PF) 100mcg/mL in 0.9% Sodium Chloride, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0934-70

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 800 units
FDA Drug Class II Terminated

Fentanyl Citrate 10mcg/mL in 0.9% Sodium Chloride, 50mL Cadd Cassette (grey), Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0505-41

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 5 units
FDA Drug Class II Terminated

Cefazolin 2GM added to 100 mL 0.9% Sodium Chloride bag Rx Only,Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0216-48

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 1083 units
NHTSA Ongoing

Inconsistent Rubber Coverage of Steel Plies

April 20, 2016 BRIDGESTONE/FIRESTONE NORTH AMERICA TIRE 8 units
FDA Drug Class II Terminated

Diltiazem HCI 250 mg in 5% Dextrose, 250 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0853-02

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 10 units
FDA Food Class II Terminated

Thin Egg Noodle (Mi Trung Ga), 5lbs, 8 units/case

April 20, 2016 Sincere Orient Commercial Foods Corp. 1,248 packages (6,240 lbs) units
FDA Drug Class II Terminated

Oxytocin 20 Units added to Lactated Ringers in a 1000 mL lntravia bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0769-04

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 384 units
FDA Drug Class II Terminated

Tien Ma Tou Tong Wan (Condensed pills), packaged in 100-count bottles within a box, Kwangchow First Chinese Medicine Factory, Kwangchow, China; remaining labeling contains Chinese characters.

April 20, 2016 Murray International Trading Co., Inc. 96 bottles units
FDA Drug Class II Terminated

Bupivacaine HCI 0.125% 50 mL fill in a 60 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0608-75

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 40 units
FDA Drug Class II Terminated

Lidocaine 2%, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0946-70

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 50 units
FDA Drug Class II Terminated

Epinephrine (PF) 10mcg/mL in 0.9% Sodium Chloride, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0135-70

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 400 units
FDA Drug Class II Terminated

HYDROmorphone HCI 1mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless Syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0932-68

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 90 units
FDA Drug Class II Terminated

Epinephrine HCI 5 mcg/mL in 0.9% Sodium Chloride, 10mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0800-72

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 1200 units
FDA Food Class II Terminated

12 Inch Message Cookies, UPC 0007203695587, 1 Pk (Pack 24/1 Ct)

April 20, 2016 Harris Teeter 8797 Units units
FDA Drug Class II Terminated

Promethazine 6.25 mg added to 0.9% Sodium Chloride 50 mL in 100 mL B/Braun PAB bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0177-41

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 40 units
FDA Drug Class II Terminated

Morphine Sulfate (PF) 0.5mg/mL in 0.9% Sodium Chloride 1mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0322-78

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 25 units
FDA Drug Class II Terminated

FUCONPO CAPSULE, packaged in a 30-count bottle within a box, remaining labeling contains Chinese characters.

April 20, 2016 Murray International Trading Co., Inc. unknown units
FDA Drug Class II Terminated

CROCODILE BILE PILL FOR ASTHMA, packaged in 100-count bottles within a box, remaining labeling contains Chinese characters.

April 20, 2016 Murray International Trading Co., Inc. 48 bottles units
FDA Drug Class II Terminated

Ketamine 2 mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoject Plungerless syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0938-68

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 150 units
FDA Drug Class II Terminated

Fentanyl Citrate 2 mcg/mL/Ropivacaine HCI 0.2% injection in 0.9% Sodium Chloride, 100 mL bag, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0029-01

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 150 bags units
FDA Drug Class II Terminated

HYDROmorphone HCI 0.2mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0702-68

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 100 units
FDA Drug Class II Terminated

Ephedrine Sulfate 5 mg/mL in 0.9% Sodium Chloride, 10 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0961-72

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 2665 units
FDA Drug Class II Terminated

GASTRODIA CAPSULES, packaged in 30-count bottles within a box, LANZHOU MANUFACTORY OF CHINA. GANSU CHINA; remaining labeling contains Chinese characters.

April 20, 2016 Murray International Trading Co., Inc. Unknown units
FDA Drug Class II Terminated

FUQINGSONG RELIEF CREAM (Flucinonide Ointment), packaged in 50-count individually labeled pieces Net Wt. 0.32oz (10g) within a box, MANUFACTURED BY: TIANJIN MAEDICAL & PHARMACEUTICAL CO., LTD. ADDREST

April 20, 2016 Murray International Trading Co., Inc. 97 boxes units
FDA Drug Class II Terminated

Atropine Sulfate 0.4mg/mL 2.5 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0867-71

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 400 units
FDA Drug Class II Terminated

Fentanyl Citrate 50 mcg/mL, 5ml syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0964-70

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 1500 units
FDA Drug Class II Terminated

Fentanyl Citrate 2.5 mcg/mL & Bupivacaine 0.075% in 0.9% Sodium Chloride, 60 mL BD syringe, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC # 45183-0826-77

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 260 units
FDA Drug Class II Terminated

HYDROmorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD syringe;, Rx Only, Compounded by PHARMAKON Pharmaceuticals, Noblesville, IN 46060, NDC 45183-0815-67

April 20, 2016 Pharmakon Pharmaceuticals, Inc. 560 units