Drugs Recalls

FDA Drug Class II Terminated

Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Cont

May 21, 2013 Baxter Healthcare Corp. N/A units

FDA Drug Class II Terminated

Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Baxter, Deerfield, IL 60015, NDC 0338-1055-48

May 21, 2013 Baxter Healthcare Corp. 172,296 units units

FDA Drug Class II Terminated

0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (NDC 0338-0553-11), b) 100 mL (NDC 0338-0553-18), Rx Only, Baxter, Deerfield, IL 60015

May 21, 2013 Baxter Healthcare Corp. 845,520 units units

FDA Drug Class II Terminated

Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per

May 21, 2013 Sun Pharmaceutical Industries Inc. 46387 Cartons units

FDA Drug Class II Terminated

Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Container Quad Pack (NDC 0338-0049-11); b) 2B1302- 100mL in Viaflex Quad Pack (NDC 0338-0049-18); c) 2B1306- 50 mL in Viaflex S

May 21, 2013 Baxter Healthcare Corp. 1,788,292 units units

FDA Drug Class II Terminated

5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015

May 21, 2013 Baxter Healthcare Corp. 730,848 units units

FDA Drug Class III Terminated

Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11

May 21, 2013 Fresenius Kabi USA, LLC 80,480 vials units

FDA Drug Class II Terminated

Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plastic Container, 500mL, Rx Only, Baxter, Deerfield, IL 60015

May 21, 2013 Baxter Healthcare Corp. N/A units

FDA Drug Class I Terminated

Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg

May 20, 2013 Sandoz Incorporated 1,635 vials units

FDA Drug Class I Terminated

XIYOUJI QINGZHI CAPSULE, 300mg, 20 count box

May 20, 2013 Dolphin Intertrade Corporation 8 bottles units

FDA Drug Class II Terminated

Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, Rx only, Sterile, NDC 0409-4755-03, Hospira, Inc, Lake Forest, IL 60045.

May 20, 2013 Hospira, Inc. 340,600 vials units

FDA Drug Class I Terminated

JaDera, 100% Natural Weight Loss Supplement, capsules, 30 count bottle

May 20, 2013 Dolphin Intertrade Corporation 998 boxes units

FDA Drug Class II Terminated

Enablex (darifenacin) Extended Release Tablet, 15 mg per tablet. Physician Sample 7 Tablets bottle, Rx only, Mfd by: Novartis Pharma Stein AG, Stein, Switzerland, NDC 0078-9420-07

May 17, 2013 Warner Chilcott US LLC 188,600 bottles units

FDA Drug Class II Terminated

West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmaceutical Corp., Ea

May 16, 2013 West-ward Pharmaceutical Corp. 14,503 bottles units

FDA Drug Class II Terminated

West-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724

May 16, 2013 West-ward Pharmaceutical Corp. 7,324 bottles units

FDA Drug Class II Terminated

Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12

May 16, 2013 Hospira, Inc. 95,700 vials units

FDA Drug Class III Terminated

Maximum Strength Comtrex ,Severe Cold & Sinus Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula and 12 coated caplets nighttime

May 15, 2013 Novartis Consumer Health 167,712/24-caplet packages units

FDA Drug Class II Terminated

Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 2500mL bag and b) 6000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothw

May 15, 2013 Pentec Health 3 Bags units

FDA Drug Class II Terminated

HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433.

May 15, 2013 Health & Beyond 46 bottles units

FDA Drug Class II Terminated

Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactured by VistaPharm, Inc., Birmingham, AL 35242. Distributed by Actavis Mid Atlantic LLC 1877 Kawai Road, Lincolnton, NC 28

May 15, 2013 Actavis South Atlantic LLC A total of 133,968 bottles (units) units

FDA Drug Class II Terminated

Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids and KCL), in 3000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA

May 15, 2013 Pentec Health 1 Bag units

FDA Drug Class II Terminated

Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in 555mL bag, Pentec Health Inc, 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

May 15, 2013 Pentec Health 59 Bags units

FDA Drug Class II Terminated

Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1000mL bag, b) 2000mL bag, c) 2500mL bag, d) 5000mL bag, and e) 6000mL bag, Pen

May 15, 2013 Pentec Health 8 Bags units

FDA Drug Class III Terminated

Maximum Strength Comtrex Day/Night Cold & Cough, Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg, Phenylephrine HCL 5mg, packaged in 16 coated caplets daytime formula an

May 15, 2013 Novartis Consumer Health 104,328/32-caplet packages units

FDA Drug Class II Terminated

Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino acids, dextrose and sterile water), in 330mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-13132

May 15, 2013 Pentec Health 1 Bag units

FDA Drug Class III Terminated

Theraflu Nighttime Warming Relief Nighttime Multi-Symptom Cold, Acetaminophen 325mg , Chlorpheniramine Maleate 2mg , Dextromethorphan HBr 10mg , Phenylephrine HCL 5mg, a) 8 coated caplets (NDC 0067-64

May 15, 2013 Novartis Consumer Health 3,768/8-caplet packages and 300,580/24-caplet packages units

FDA Drug Class III Terminated

Maximum Strength Comtrex Nighttime Cold & Cough, Acetaminophen 325mg ,Chlorpheniramine Maleate 2mg, Dextromethorphan HBR 10mg,Phenylephrine HCL 5mg, packaged in 24 coated caplets nighttime formula

May 15, 2013 Novartis Consumer Health 32,256/24-caplet packages units

FDA Drug Class II Terminated

Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 3000mL bag, b) 5000mL bag and c) 6000mL bag, Pentec Health Inc., 4 Creek Parkway

May 15, 2013 Pentec Health 5 Bags units

FDA Drug Class II Terminated

Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 805mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

May 15, 2013 Pentec Health 1 Bag units

FDA Drug Class II Terminated

Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 710mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

May 15, 2013 Pentec Health 1 Bag units

FDA Drug Class III Terminated

Maximum Strength Comtrex , Day/Night Flu Therapy , Acetaminophen 325mg, Chlorpheniramine Maleate 2mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in 12 coated caplets daytime formula a

May 15, 2013 Novartis Consumer Health 38,856/24-caplet package units

FDA Drug Class II Terminated

Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 385mL and b) 390mL, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

May 15, 2013 Pentec Health 9 Bags units

FDA Drug Class II Terminated

IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), a) 490mL bag, b) 500mL bag, and c) 590mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-31

May 15, 2013 Pentec Health 3 Bags units

FDA Drug Class III Terminated

Excedrin, Sinus Headache, Acetaminophen 325mg, Phenylephrine HCL 5mg , 2 caplets. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ. 07054-0622, NDC 0067-2062-02.

May 15, 2013 Novartis Consumer Health 2,978,000/2-caplet packages units

FDA Drug Class II Terminated

Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), 1000mL bag, Pentec Health Inc., 4 Creek Parkway Suite A, Boothwyn, PA 19061-3132

May 15, 2013 Pentec Health 1 Bag units

FDA Drug Class II Terminated

Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution with added amino acids), in a) 485mL bag and b) 490mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-3

May 15, 2013 Pentec Health 25 Bags units

FDA Drug Class II Terminated

Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in 435mL bag, Pentec Health Inc., 4 Creek Parkway Suite A Boothwyn, PA 19061-3132

May 15, 2013 Pentec Health 4 Bags units

FDA Drug Class III Terminated

Theraflu Warming Relief, Multi-Symptom Cold, Acetaminophen 325mg, Dextromethorphan HBr 10mg, Phenylephrine HCL 5mg, packaged in a) 8 coated caplets (NDC 0067-6438-08) b) 24 coated caplets (NDC 0067-64

May 15, 2013 Novartis Consumer Health 98,024/8-caplet packages and 557,548/24-caplet packages units

FDA Drug Class III Terminated

Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 265

May 15, 2013 Mylan Institutional, Inc. (d.b.a. UDL Laboratories) 1,621 boxes units

FDA Drug Class II Terminated

Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 1500mL and b) 3000mL bags. Pentec Health Inc., 4 Creek Parkway Suite A, Booth

May 15, 2013 Pentec Health 3 units units

FDA Drug Class II Terminated

Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution with added amino acids), in a) 635mL bag and b) 660mL bag, Pentec Health Inc 4 Creek Parkway Suite A Boothwyn, PA 19061-313

May 15, 2013 Pentec Health 38 Bags units

FDA Drug Class I Terminated

Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534,

May 13, 2013 Zydus Pharmaceuticals USA Inc 960 Bottles units

FDA Drug Class I Terminated

Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as sulfate), 0.4 mg Copper (as sulfate), 0.1 mg Manganese (as sulfate), 4 mcg Chromium (as chloride), 20 mcg Selenium (as sod

May 13, 2013 Abrams Royal Pharmacy 21 vials units

FDA Drug Class III Terminated

Nicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --

May 13, 2013 West-ward Pharmaceutical Corp. Lot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials units

FDA Drug Class I Terminated

Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp

May 10, 2013 Apotex Corp. 52,398 vials units

FDA Drug Class II Terminated

Dicopanol FusePaq Kit for Oral Suspension, 5mg/ML

May 8, 2013 Fusion Pharmaceuticals, LLC 1,200 kits units

FDA Drug Class III Terminated

Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil (SCALP OIL), 0.01 %, 118.28 mL (4 Fl. oz.) bottle, Rx only, Manufactured and Distributed by: Hill Dermaceuticals, Inc. SANFORD, FLORIDA 32773; NDC

May 7, 2013 Hill Dermaceuticals, Inc. 8,808 bottles units

FDA Drug Class I Terminated

Lightning ROD capsules, 500 mg/capsule, packaged in 3-count bottles (UPC 6 89076 20257 2).

May 6, 2013 Chang Kwung Products 3,720 capsules total units

FDA Drug Class I Terminated

Lightning ROD capsules, 550 mg/capsule, packaged in 12-count bottles (UPC 6 89076 20297 8).

May 6, 2013 Chang Kwung Products 3,720 capsules total units

FDA Drug Class II Terminated

Pure-Aid Allergy Relief, Diphenhydramine HCL Caplets, 25 mg, 20 caplets, Exclusively distributed by: Kareway Products Inc., Compton, CA --- UPC 8 56023 00158 2

May 3, 2013 Kareway Product Inc 24,048 cartons units