Drugs Recalls

FDA Drug Class II Terminated

Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01

June 18, 2013 Teva Pharmaceuticals USA, Inc. 13,478 bottles units

FDA Drug Class II Terminated

Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health

June 18, 2013 Novartis Consumer Health 1,140,564 cartons units

FDA Drug Class II Terminated

Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Green Tea & Honey Lemon flavors, packaged in a) 6-coun

June 18, 2013 Novartis Consumer Health 1,202,960 cartons and cards units

FDA Drug Class II Terminated

NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single

June 18, 2013 Novartis Consumer Health

FDA Drug Class II Terminated

Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets, Natural Citrus flavor, 6-count packets per carton,

June 18, 2013 Novartis Consumer Health 868,104 cartons units

FDA Drug Class II Terminated

Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 50

June 18, 2013 Novartis Consumer Health

FDA Drug Class II Terminated

NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per c

June 18, 2013 Novartis Consumer Health

FDA Drug Class II Terminated

NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Nova

June 18, 2013 Novartis Consumer Health

FDA Drug Class II Terminated

Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol &

June 18, 2013 Novartis Consumer Health 917,400 cartons units

FDA Drug Class II Terminated

Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01

June 18, 2013 Teva Pharmaceuticals USA, Inc. 7,579 bottles units

FDA Drug Class II Terminated

Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per

June 18, 2013 Novartis Consumer Health 292,320 cartons units

FDA Drug Class II Terminated

Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsip

June 18, 2013 Novartis Consumer Health 398,208 cartons units

FDA Drug Class II Terminated

Belladonna Alkaloids/PB (Belladonna Alkaloids / Phenobarbital) Tablets Phenobarbital USP 16.2 mg, Hyoscyamine Sulfate 0.1037 mg, Atropine Sulfate 0.0194 mg, Scopolamine Hydrobromide 0.0065 mg 30-c

June 17, 2013 Physicians Total Care, Inc. 270 tablets units

FDA Drug Class I Terminated

ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9.

June 17, 2013 Advance Pharmaceutical Inc 16,440 bottles units

FDA Drug Class III Terminated

Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20

June 14, 2013 Boehringer Ingelheim Roxane Inc 14,619 cartons units

FDA Drug Class II Terminated

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.

June 13, 2013 Carefusion 213, Llc 23,000 Applicators units

FDA Drug Class III Terminated

Medroxyprogesterone acetate, micronized (EP, USP) active pharmaceutical ingredient, Rx only, packaged in 6.0 kg drums (labeled as 6,000 kg), Bayer Schering Pharma AG, D-13342 Berlin

June 13, 2013 Bayer HealthCare Pharmaceuticals Inc. 194.62 kg units

FDA Drug Class II Terminated

Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP3 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b)

June 11, 2013 Church & Dwight Inc 749 tons total units

FDA Drug Class II Terminated

Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, Sodium Bicarbonate U.S.P. No. 4 Granular, Net Wt. 50 lbs. (22.68 kg.) per bag, Manufactured by: Church & Dwight Co., Inc., 469 N. Harrison St., P

June 11, 2013 Church & Dwight Inc 749 tons total units

FDA Drug Class I Terminated

Bethel 30 capsules, packaged in 30 count bottles, Distributed by BETHEL INC. New York, New York

June 11, 2013 Bethel Nutritional Consulting, Inc 18,678 bottles units

FDA Drug Class II Terminated

Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP2 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b)

June 11, 2013 Church & Dwight Inc 749 tons total units

FDA Drug Class II Terminated

Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP5 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b)

June 11, 2013 Church & Dwight Inc 749 tons total units

FDA Drug Class II Terminated

Sodium Bicarbonate Powder, CAS-144-55-8, Arm & Hammer, labeled as a) USP1 Grade, packaged in bags of various quantities, Church & Dwight Co, Inc., 469 N. Harrison St., Princeton, NJ 08543-5297; and b)

June 11, 2013 Church & Dwight Inc 749 tons total units

FDA Drug Class II Terminated

VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconstituted to 10 mL, for IV single use only, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195 (USA); Mfd. by MN Ph

June 7, 2013 Sagent Pharmaceuticals Inc 831,950 vials units

FDA Drug Class II Terminated

No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 2070 02

June 6, 2013 Novartis Consumer Health 4,422,000 pouches units

FDA Drug Class II Terminated

0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Container, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7983-02

June 6, 2013 Hospira, Inc. 676,872 containers units

FDA Drug Class II Terminated

Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes of 50/2-ct packages, Distributed by Novartis Consumer Health, Inc., Pars

June 6, 2013 Novartis Consumer Health a) 4,178,000 pouches; b) 101,300 boxes and c) & d) 38,235 pouches and boxes (combined) units

FDA Drug Class II Terminated

Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches, Distributed by Novartis Consumer Health, Inc., Parsippany, NJ, NDC 0067 203

June 6, 2013 Novartis Consumer Health 10,624,000 pouches units

FDA Drug Class II Terminated

Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count pouches, Distributed by Novartis Consumer Health, Inc., USA and Novartis C

June 6, 2013 Novartis Consumer Health 472,000 pouches units

FDA Drug Class II Terminated

Cleocin Phosphate (clindamycin Injection), USP, a) 600 mg/4mL (150 mg/mL) ADD-Vantage Vial, b) 900 mg/6mL (150 mg/mL) ADD-Vantage Vial, Rx Only, For Intravenous Use Only, Use Only with the ADD-Vantage

June 4, 2013 Pharmacia & Upjohn LLC 898,900 Vials units

FDA Drug Class II Terminated

VersaPharm Incorporated, Ethambutol Hydrochloride Tablets, USP 400 mg 60 tablets, Rx Only, Mfd. for VersaPharm Incorporated Marietta, GA 30065-1509; Mfd. by: West-ward Pharmaceuticals Corp., Eatontown

June 4, 2013 West-ward Pharmaceutical Corp. 118 bottles units

FDA Drug Class III Terminated

Fentanyl Transdermal System, 50 mcg/h, 1 system per pouch (NDC 0591-3212-54), packaged in 5-count systems per box (NDC 0591-3212-72), Rx only, Manufactured by Watson Laboratories, Inc, Corona, CA, 928

June 3, 2013 Actavis 98,952 boxes units

FDA Drug Class III Terminated

Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/5.0 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA 1910, NDC 0046-0975-11

May 31, 2013 Pfizer Inc. 135,520 blister cards units

FDA Drug Class I Terminated

Calcium Chloride Preservative Free Sterile injection, 100 mg/ml, 10 ml vial, Rx only, Abrams Royal Compounding Pharmacy, 8220 Abrams Rd, Dallas, TX 75231.

May 31, 2013 Abrams Royal Pharmacy 1,100 vials units

FDA Drug Class III Terminated

Prempro (Conjugated Estrogen/Medroxyprogesterone Acetate) tablets 0.625 mg/2.5 mg, 1 blister card containing 28 tablets, Rx only, Wyeth Pharmaceuticals Inc., Philadelphia, PA, NDC 0046-0875-11

May 31, 2013 Pfizer Inc. 432,657 blister cards units

FDA Drug Class III Terminated

Norpace CR (disopyramide phosphate) extended-release capsules USP,150 mg, packaged in a) 100-count bottles (NDC 0025-2742-31), and b) 500-count bottles (NDC 0025-2742-51), Rx only, Distributed by G.D.

May 31, 2013 Pfizer Inc. 5,410 botlles units

FDA Drug Class III Terminated

Pharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirt

May 30, 2013 Pharmalucence, Inc. 17,260 vials units

FDA Drug Class II Terminated