Drugs Recalls

FDA Drug Class II Terminated

Thyro-Tab 0.088 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

July 9, 2012 Lloyd Inc. of Iowa 3,826,269 tablets units

FDA Drug Class II Terminated

Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

July 9, 2012 Lloyd Inc. of Iowa 1,923,887 tablets units

FDA Drug Class II Terminated

Levothroid (levothyroxine sodium tablets, USP), 112 mcg., 100-count bottles, Rx only, NDC 0456-1330-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Lo

July 9, 2012 Lloyd Inc. of Iowa 37,827/100-tablet bottles units

FDA Drug Class II Terminated

Levothroid (levothyroxine sodium tablets, USP), 88 mcg., 100-count bottles, Rx only, NDC 0456-1329-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Loui

July 9, 2012 Lloyd Inc. of Iowa 31,252/100-tablet bottles units

FDA Drug Class II Terminated

Levothroid (levothyroxine sodium tablets, USP), 137 mcg., 100-count bottles, Rx only, NDC 0456-1331-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Lo

July 9, 2012 Lloyd Inc. of Iowa 36,978/100-tablet bottles units

FDA Drug Class II Terminated

Thyro-Tab 0.300 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

July 9, 2012 Lloyd Inc. of Iowa 1,902,957 tablets units

FDA Drug Class II Terminated

Levothroid (levothyroxine sodium tablets, USP),125 mcg., 100-count bottles, Rx only, NDC 0456-1324-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Lou

July 9, 2012 Lloyd Inc. of Iowa 19,162/100-tablet bottles units

FDA Drug Class II Terminated

Thyro-Tab 0.137 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

July 9, 2012 Lloyd Inc. of Iowa 3,774,541 tablets units

FDA Drug Class II Terminated

Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Lou

July 9, 2012 Lloyd Inc. of Iowa 13,692/100-tablet bottles units

FDA Drug Class II Terminated

Thyro-Tab 0.125 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

July 9, 2012 Lloyd Inc. of Iowa 1,924,174 tablets units

FDA Drug Class II Terminated

Thyro-Tab 0.112 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA.

July 9, 2012 Lloyd Inc. of Iowa 3,813,645 tablets units

FDA Drug Class II Terminated

Levothroid (levothyroxine sodium tablets, USP), 300 mcg., 100-count bottles, Rx only, NDC 0456-1328-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Lo

July 9, 2012 Lloyd Inc. of Iowa 1,443/100-tablet bottles units

FDA Drug Class III Terminated

HYDROCORTISONE and ACETIC ACID OTIC SOLUTION, USP, 10 mL bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811; NDC 0603-7039-39; UPC 3 0603-7039-39 7.

July 6, 2012 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals 54,431 bottles units

FDA Drug Class III Terminated

HYDROXYZINE HYDROCHLORIDE ORAL SOLUTION, USP, 10 mg/5 mL, 1 PINT (473 mL) bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-1310-58, UPC 3 0603-1310-58 4.

July 6, 2012 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals 73,746 bottles units

FDA Drug Class II Terminated

NAPROXEN TABLETS USP, 500 mg, 100-count Tablets per bottle, Rx only, Manufactured by: Glenmark Generics Ltd., Colvale-Bardez, Goa 403513, India; Manufactured for: Glenmark Generics Inc., USA, Mahwah,

July 6, 2012 Glenmark Generics Inc., USA unknown units

FDA Drug Class II Terminated

Leucovorin Calcium Injection USP, single use vials, 10mg/mL; 50mL, Rx only, Manufactured by: Ben Venue Labs, Inc., Bedford, OH 44146, NDC# 55390-009-01(Bedford); NDC# 55390-826-01(Novaplus)

July 5, 2012 Ben Venue Laboratories Inc 226,010 vials units

FDA Drug Class III Terminated

Nexium (esomeprazole magnesium) Delayed-Release Capsules, 40 mg, 1000-count bottle, Rx only, Manufactured for: AstraZeneca LP, Wilmington, DE 19850; By: AstraZeneca AB, S-151 85 Sodertalje, Sweden, N

July 2, 2012 ASTRA ZENECA Lp 2,556 bottles units

FDA Drug Class III Terminated

Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx only, Hospira,

July 2, 2012 Hospira, Inc. 77,542 vials units

FDA Drug Class II Terminated

Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01

June 29, 2012 Mylan LLC. 15181 bottles. units

FDA Drug Class II Terminated

Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Co

June 29, 2012 Prometheus Laboratories Inc. a) 25,516 bottles; b) 2,569 bottles units

FDA Drug Class III Terminated

Super Colon Cleanse, stimulant laxative, 140 mg of Senna per capsule, 25 doses, 100 capsules, Manufactured by: healthPLUS Inc. Chino, CA 91710 USA.

June 28, 2012 Health Plus Incorporated 24,423 bottles units

FDA Drug Class III Terminated

Famotidine Tablets USP, 20 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-3020-01

June 28, 2012 Mylan Pharmaceuticals Inc. 31,867 Bottles units

FDA Drug Class II Terminated

Methotrexate Injection, USP, 25 mg/mL, 40 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-408-41

June 27, 2012 Hospira, Inc. 34,572 vials units

FDA Drug Class II Terminated

Cytarabine Injection, 20 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; NDC 61703-303-46

June 27, 2012 Hospira, Inc. 210 vials units

FDA Drug Class II Terminated

Carboplatin Injection, 10 mg/mL, 45 mL Multi-Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-50 (Hospira

June 27, 2012 Hospira, Inc. 30,582 vials units

FDA Drug Class II Terminated

Paclitaxel Injection, 6 mg/mL, 50 mL Single Dose Vial, Rx only, antineoplastic/cytotoxic agent; Manufactured for Hospira, Inc., Lake Forest, IL 60045, Product of Australia; N DC 61703-342-50

June 27, 2012 Hospira, Inc. 131,264 vials units

FDA Drug Class I Terminated

Vecuronium Bromide for Injection, For IV use only, 20 mg per vial, 10 x 10 mg Vials, lyophilized powder per carton, Rx Only, Mfr. By: Ben Venue Laboratories, Bedford, OH 44146: Mfg for: Bedford Labs,

June 26, 2012 Ben Venue Laboratories Inc 797 boxes/10/20 mg vials units

FDA Drug Class II Terminated

OXYGEN, COMPRESSED USP MEDICAL GAS in the following containers: E Cylinder 680L, D Cylinder 425L, and M6 Cylinder 165L, Rx only, Oklahoma Respiratory Care, Norman, OK

June 21, 2012 Oklahoma Respiratory Care Inc 861 cylinders units

FDA Drug Class III Terminated

Lactated Ringer's Injection, USP, 1000 mL, Rx only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09

June 21, 2012 Hospira, Inc. 1,296 units units

FDA Drug Class II Terminated

Little Remedies For Tummys, Stimulant Laxative (sennosides) Drops, 1 FL OZ (30 mL), Dist. by Medtech Products Inc., Irvington, NY 10533, UPC 7 56184 12071 2.

June 20, 2012 Medtech Products, Inc. 12,720 bottles units

FDA Drug Class III Terminated

Tobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,

June 18, 2012 Stat Rx USA 22 units units

FDA Drug Class II Terminated

Kleenex Foam Hand Sanitizer, Alcohol Free in a) 1.5 fl oz. (45mL) , b) 8 fl oz. (236mL) , and c) 16 fl oz (473mL) bottles, Distributed by Kimberly Clark, LLC, Roswell, GA 30076

June 14, 2012 Kimberly-Clark Corporation 8994 Bottles units

FDA Drug Class II Terminated

Kleenex Luxury Foam Hand Sanitizer, (Benzalkonium Chloride 0.1%), in a) 1 Liter (33.8 fl oz.), b) 1.2 Liters (40.5 fl oz.) Cassettes, Distributed by Kimberly Clark, LLC, Roswell, GA 30076

June 14, 2012 Kimberly-Clark Corporation 5268 Cassettes units

FDA Drug Class II Terminated

ZEE Antiseptic Wipes, First Aid Antiseptic, Benzalkonium chloride 0.133% (effective concentration), over the counter; supplied in 10 (item 2633), 50 (items 0204 and 02040 [sold in Canada only]) and 10

June 14, 2012 Dukal Corp.

FDA Drug Class II Terminated

Dukal Corporation BZK Swab, First Aid Antiseptic, (Benzalkonium Chloride), 0.133% w/v, Item 854-1000 contains 1000 individually packaged swabs per box. Item 854 contains 200 individually packaged swab

June 14, 2012 Dukal Corp.

FDA Drug Class III Terminated

Erythromycin Topical Solution USP, 2%, 60 mL bottle with applicator, Rx only. E. FOUGERA & CO., A division of Fougera Pharmaceuticals, Inc., Melville, New York 11747, NDC 0168-0215-60, UPC 3 0168-0215

June 7, 2012 Fougera Pharmaceuticals, Inc. 444 bottles units

FDA Drug Class II Terminated

Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors per carton, Rx only, Meridian Medical Technologies, Columbia, MD 21046; A subs

June 6, 2012 Meridian Medical Technologies a Pfizer Company 83,400 autoinjectors units

FDA Drug Class II Terminated

Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 6 Tablets per Carton, 2.5 mg/1000 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Pri

June 5, 2012 Bristol-myers Squibb Company 117,049 Sample Cartons units

FDA Drug Class III Terminated

Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-co

June 5, 2012 Watson Laboratories Inc 18,938 cartons units

FDA Drug Class III Terminated

Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02

June 5, 2012 JHP Pharmaceuticals, LLC 26100 vials units

FDA Drug Class II Terminated

Kombiglyze XR (saxagliptin and metformin HCl extended-release) tablets, Physician Sample-Not For Sale, 7 Tablets per Carton, 5 mg/500 mg, Rx only, Manufactured By: Bristol-Myers Squibb Company, Prince

June 5, 2012 Bristol-myers Squibb Company N/A units

FDA Drug Class II Terminated

Trizivir (abacavir sulfate 300mg, lamivudine 150 mg and zidovudine 300 mg), 60 Tablets, Rx only, Manufactured for: ViiV Healthcare, Research Triangle Park, NC 27709 by: GlaxoSmithKline, Research Trian

June 4, 2012 GlaxoSmithKline Inc 14,465 bottles units

FDA Drug Class II Terminated

CARDIOGEN-82 (Rubidium Rb 82 Generator), 140 millicurie, Rx Only, For Elution of sterile nonpyrogenic Rubidium Chloride Rb 82, Manufactured for: Bracco Diagnostics Inc. Princeton, NJ 08543 by Medi-Phy

June 1, 2012 Bracco Diagnostics Inc 54 generators units

FDA Drug Class III Terminated

Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2

May 31, 2012 Bayer HealthCare Pharmaceuticals Inc. 138,505 vials units

FDA Drug Class II Terminated

Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Man

May 30, 2012 VistaPharm, Inc. a) 949 Cases, b) 188 bottles units

FDA Drug Class II Terminated

GANCYCLOVIR, SDPF - (30G, 1/2" SYRINGE) 20MG/ML INJECTABLE 1 ML (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 1 unit units

FDA Drug Class II Terminated

HYALURONIDASE/METHYLPREDNISOLONE ACETATE, P.F. 37.5U/20MG/ML INJECTABLE 20 ML (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 4 units units

FDA Drug Class II Terminated

DMSO/HEPARIN/METHYLPREDNISOLONE 50%/5000U/40MG/50ML SOLUTION 300 MLS (1 PRODUCT)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 2 units units

FDA Drug Class II Terminated

G-C-P 0.1%/0.1%/0.05% SOLUTION 250 ML, 250 MLS, 500 ML (3 DIFFERENT PRODUCTS)

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 6 units units

FDA Drug Class II Terminated

BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML; BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 50MCG/2MG/200MCG/50MG/ML INTRATHEC 18 ML; BACLOFEN/CLONIDINE/BUPIV

May 25, 2012 Franck's Lab Inc., d.b.a. Franck's Compounding Lab 10 units units