Drugs Recalls

FDA Drug Class II Terminated

Atorvastatin Calcium Tablets, 10 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, Ind

November 9, 2012 Ranbaxy Inc. 120,201 Bottles units

FDA Drug Class II Terminated

Atorvastatin Calcium Tablets, 20 mg, 90 tablets per bottle, Rx only, Manufactured for: Ranbaxy Pharmaceuticals Inc., Jacksonville, FL 32257, USA, by: Ranbaxy Laboratories Ltd., New Delhi - 110019, Ind

November 9, 2012 Ranbaxy Inc. 203,198 Bottles units

FDA Drug Class I Completed

Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56.

November 8, 2012 Hospira, Inc. 23,315 vials units

FDA Drug Class II Terminated

Vicks NyQuil Cold & Flu, Nighttime Relief, 12 FL OZ bottle, Dist. by Proctor and Gamble, Cincinnati, OH 45040. NDC 37000-808-12

November 8, 2012 Procter & Gamble Co 17,532 bottles units

FDA Drug Class I Completed

Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira,

November 8, 2012 Hospira, Inc. 31,326 vials units

FDA Drug Class II Terminated

VIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham,

November 6, 2012 Alkermes, Inc. 3,325 vials units

FDA Drug Class II Terminated

Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54

November 5, 2012 Boehringer Ingelheim Roxane Inc 8,381 bottles units

FDA Drug Class II Terminated

traMADOL Hydrochloride Tablets, USP 50 mg, 1000-count tablets per bottle, Manufactured by: Sun Pharmaceuticals Industries, Dadra 396 191, India; Distributed by: Caraco Pharmaceutical Laboratories, Ltd

November 5, 2012 Caraco Pharmaceutical Laboratories Ltd. 2,264 bottles units

FDA Drug Class II Terminated

ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35

November 2, 2012 Bristol Myers Squibb Manufacturing Company 21 blister packs units

FDA Drug Class II Terminated

All Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com

October 31, 2012 Ameridose LLC

FDA Drug Class II Terminated

All Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com

October 31, 2012 Ameridose LLC

FDA Drug Class II Terminated

Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR

October 29, 2012 Alara Pharmaceutical Co 7,432 bottles units

FDA Drug Class II Terminated

Epinephrine Injection USP, 1 mL, USP 1:1000 (1 mg/mL), SQ/IM, Hospira, Inc., Lake Forest, IL --- NDC 0409-7241-01

October 25, 2012 Hospira, Inc. 361,600/1-mL ampules units

FDA Drug Class III Terminated

Advair HFA (fluticasone propionate 45 mcg and salmeterol 21 mcg) Inhalation Aerosol, 12g, 120 Metered Actuations, For Oral Inhalation with Advair HFA actuator only, Rx only, GlaxoSmithKline, Research

October 24, 2012 GlaxoSmithKline, LLC. 310,964 Aerosol Units units

FDA Drug Class III Terminated

Advair HFA (fluticasone propionate/salmeterol) Inhalation Aerosol, 45mcg/21 mcg 60 Actuations INST, NDC 0173-0715-22, Rx only, GlaxoSmithKline, Research Triangle Park, NC 27709.

October 24, 2012 GlaxoSmithKline, LLC. 18,676 Aerosol Units units

FDA Drug Class III Terminated

ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF15, All Skin types, 1.7 FL. OZ. LIQ/50 ml (tube inside a unit carton) with UPC No. 271317

October 23, 2012 Estee Lauder Inc 1.7 oz. 241,236 tubes; 1.5 mL sample size 544,548 foil packs units

FDA Drug Class II Terminated

HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54

October 22, 2012 Hospira, Inc. 11,412 bags units

FDA Drug Class I Terminated

Ultimate Formula, Net Wt. 250 mg, 48 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 7 9357304140 1

October 22, 2012 Zi Xiu Tang Success, LLC 16126 bottles units

FDA Drug Class I Terminated

Classic Zi Xiu Tang, Bee Pollen Capsule, Net Wt. 250 mg x 60 capsules per bottle, Distributed by: Zi Xiu Tang Success, LLC., Trexlertown, PA 18087, UPC 6 937000 700019

October 22, 2012 Zi Xiu Tang Success, LLC 6084 bottles units

FDA Drug Class II Terminated

Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactur

October 19, 2012 Watson Laboratories Inc 1,684 cartons units

FDA Drug Class II Terminated

Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson

October 19, 2012 Watson Laboratories Inc 30,267 cartons units

FDA Drug Class II Terminated

Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson

October 19, 2012 Watson Laboratories Inc 6,466 cartons units

FDA Drug Class II Terminated

Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, I

October 19, 2012 Watson Laboratories Inc 12,333 cartons units

FDA Drug Class II Terminated

Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson La

October 19, 2012 Watson Laboratories Inc 67,860 cartons units

FDA Drug Class III Terminated

AcneFree Severe Maximum Strength Acne Pore Cleanser (benzoyl peroxide 5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13350 9.

October 15, 2012 Valeant Pharmaceuticals 10,434 canisters units

FDA Drug Class III Terminated

AcneFree Original Strength Terminator (benzoyl peroxide 5% w/v), 1 oz. (28 g) tube, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0402, UPC 7 88521 12030 7.

October 15, 2012 Valeant Pharmaceuticals 619,029 tubes units

FDA Drug Class III Terminated

AcneFree Acne Astringent Toner Pads (salicylic acid 2% w/v); 60-count pads per jar, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13551 6.

October 15, 2012 Valeant Pharmaceuticals 71,369 jars units

FDA Drug Class III Terminated

AcneFree 24 Hour Severe Acne Clearing System containing 1-count 4 fl oz (118 mL) bottle Antibacterial Cleansing Wash (benzoyl peroxide 2.5% w/v) AFSV-0101-00, 1-count 4 fl oz (118 mL) bottle Correctiv

October 15, 2012 Valeant Pharmaceuticals 477,107 cartons units

FDA Drug Class III Terminated

AcneFree Acne Pore Cleanser (benzoyl peroxide 2.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13546 2.

October 15, 2012 Valeant Pharmaceuticals 115,785 canisters units

FDA Drug Class III Terminated

AcneFree 24 Hour Clearing System containing 1-count 4 fl oz (118 mL) Oil-Free Purifying Cleanser (benzoyl peroxide 2.5% w/v) AFCS-0101-00, 1-count 4 fl oz (118 mL) Renewing Toner AFCS-0201-01, and 1-c

October 15, 2012 Valeant Pharmaceuticals 1,097,846 cartons units

FDA Drug Class III Terminated

AcneFree Oil-Free Acne Cleanser (benzoyl peroxide 2.5% w/v), 8 fl. oz. (237 mL) bottle, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, AFCS-0101-00, UPC 7 88521 12020 8.

October 15, 2012 Valeant Pharmaceuticals 145,650 bottles units

FDA Drug Class III Terminated

AcneFree 3-in-1 Acne Night Repair Foam (retinol + salicylic acid 1.5% w/v), 3 oz (85 g) canister, Dist. by: University Medical Pharmaceuticals Corp., Irvine, CA 92618, UPC 7 88521 13548 6.

October 15, 2012 Valeant Pharmaceuticals 81,319 canisters units

FDA Drug Class II Terminated

Perphenazine Tablets, USP, 8 mg, 100-count tablets per bottle, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, NDC 0603-5092-21.

October 11, 2012 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals 2,755 bottles units

FDA Drug Class II Terminated

QUETIAPINE Fumarate Tablets 25mg 100 Tablets (10x10) Blister card, Rx, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 68084-530-01

October 10, 2012 American Health Packaging 19060 blister cards units

FDA Drug Class II Terminated

Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06

October 8, 2012 GlaxoSmithKline, LLC. 1,319 vials units

FDA Drug Class II Terminated

All Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com

October 6, 2012 New England Compounding Center

FDA Drug Class II Terminated

All Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com

October 6, 2012 New England Compounding Center

FDA Drug Class I Terminated

Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible containers, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7929-09.

October 5, 2012 Hospira, Inc. 136,224 flexible containers units

FDA Drug Class II Terminated

Colloidal Silver, 100 ppm TDS, Natural Mineral Supplement, sold in a) 2 fl.oz (59.15 mL), b) 8 fl.oz (236.6 mL), c) 16 fl.oz (473.2 mL), d) 32 fl.oz (946.4 mL), e) 64 fl.oz (1.89 L), and f) 1 Gal. (3.

October 5, 2012 Earthborn Products, Inc. 161 gallons units

FDA Drug Class II Terminated

Lidocaine HCl Injection, USP, 1% (10 mg/mL), 30 mL Single-dose Teartop Vial, packaged in 25-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045; NDC 0409-4279-02.

October 4, 2012 Hospira, Inc. 120,350 vials units

FDA Drug Class II Terminated

Moexipril HCl Tablets 7.5mg, 100 tabs, Rx Only, Paddock Laboratories, Inc., Minneapolis, MN 55427, NDC 0574-0110-01 ,

October 3, 2012 Paddock Laboratories, LLC 2267 bottles units

FDA Drug Class III Terminated

Lemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)], labeled as a) Genuine Joe Cleaning Supplies, Lemon Scent, Ant

September 28, 2012 ITW Dymon a) 216 cases; b) 75 cases; c) 29 cases units

FDA Drug Class III Terminated

CellCept (mycophenolate mofetil) capsules, 250 mg, packaged in a) 12 x 120-count bottles per carton, NDC 0004-0259-05; b) 120-count capsules per bottle, NDC 0004-0259-51; Made in Ireland; Distributed

September 27, 2012 Genentech Inc 1128 bottles units

FDA Drug Class II Terminated

MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only. APP Pharmaceuticals, LLC. Schaumburg, IL 60173. NDC: 63323-412-25.

September 27, 2012 Fresenius Kabi USA, LLC 101,200 Vials units

FDA Drug Class II Terminated

ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-373-02

September 27, 2012 Fresenius Kabi USA, LLC 184,550 Vials units

FDA Drug Class II Terminated

Dr. Reddy's Quetiapine Fumarate Tablets, 25mg, Rx Only, 500 tablets. Mfd By: Dr. Reddy's Laboratories Limited, Bachepalli - 502 325, India NDC 55111-249-05

September 27, 2012 Dr. Reddy's Laboratories, Inc. 1512 bottles units

FDA Drug Class II Terminated

CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials, Rx only. APP Pharmaceuticals, LLC, Schaumburg, IL 60173. NDC: 63323-044-01.

September 27, 2012 Fresenius Kabi USA, LLC 240,550 Vials units

FDA Drug Class II Terminated

Glycerin 100% PF, 1mL, 2 mL, and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 165 vials units

FDA Drug Class II Terminated

Dexamethasone Sodium Phosphate 4 mg/mL vials PF, 6 mg/mL PF vials, and 8 mg/mL PF vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 20 vials units

FDA Drug Class I Terminated

Methylprednisolone Acetate (PF) 40 mg/ml Injection, supplied in 1 mL, 2 mL and 5 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 9062 vials units