Drugs Recalls

FDA Drug Class II Terminated

Isovue 200 mg/mL PF and 300 mg/mL PF, Vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 7055 vials units

FDA Drug Class II Terminated

Hyaluronidase 150 u/ml PF, 1 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 10,865 vials units

FDA Drug Class II Terminated

Lidocaine 1% PF, 2% PF, and 4% PF, in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 3,321 vials units

FDA Drug Class I Terminated

Methylprednisolone Acetate 40 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 5130 vials units

FDA Drug Class II Terminated

Betamethasone Sodium Phosphate 6 mg/mL P Injection, Betamethasone Sodium Phosphate 6 mg/mL PF Injection, Betamethasone Sodium Phosphate 8 mg/mL PF Injection, Betamethasone Sodium Phosphate 12 mg/m

September 26, 2012 New England Compounding Center N/A units

FDA Drug Class II Terminated

Bupivacaine 0.25% PF, Bupivacaine 0.5% PF, and Bupivacaine 0.75% PF, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center N/A units

FDA Drug Class II Terminated

Saline 10% and 3%, in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 54 vials units

FDA Drug Class II Terminated

Betamethasone Repository 6 mg/mL PF Injection and Betamethasone Repository 6 mg/mL P Injection, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center N/A units

FDA Drug Class I Terminated

Methylprednisolone Acetate (PF) 80 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 23,897 vials units

FDA Drug Class II Terminated

Omnipaque 240mg/mL PF, 300mg/mL PF, in 3 mL, 5 mL, and 10 mL, vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 8919 vials units

FDA Drug Class II Terminated

Clonidine 100 mcg/mL PF, 1mL and 2 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 2747 vials units

FDA Drug Class II Terminated

Triamcinolone 10 mg/mL P, 40mg/mL P, 40mg/mL PF and 80 mg/mL PF in 1 mL, 2 mL, 5 mL, and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 56,655 vials units

FDA Drug Class II Terminated

Lidocaine/Dextrose 5%/7.5% PF, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center N/A units

FDA Drug Class I Terminated

Methylprednisolone Acetate 80 mg/mL Injection, Preserved, supplied in 5 mL and 10 mL vials, manufactured by New England Compounding Center, Framingham, MA

September 26, 2012 New England Compounding Center 3822 vials units

FDA Drug Class II Terminated

5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03

September 21, 2012 Baxter Healthcare Corp. 5,064 containers units

FDA Drug Class II Terminated

10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03

September 21, 2012 Baxter Healthcare Corp. 2,976 containers units

FDA Drug Class II Terminated

Limed Bone Gelatin, packaged in six 125 kg fiber drums and labeled in part PO NO.: P8095 GELATIN 75 BLOOM ITEM NO. RM 164. MADE IN INDIA

September 21, 2012 American Enterprises LLC dba Sterling Gelatin 750 kgs units

FDA Drug Class I Terminated

Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured By: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 00591-0540-05.

September 21, 2012 Watson Laboratories Inc 4,874 bottles units

FDA Drug Class II Terminated

0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Hea

September 21, 2012 Baxter Healthcare Corp. 897,496 containers units

FDA Drug Class II Terminated

5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Co

September 21, 2012 Baxter Healthcare Corp. 753,941 containers units

FDA Drug Class II Terminated

Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Health

September 21, 2012 Baxter Healthcare Corp. 55,664 containers units

FDA Drug Class II Terminated

Nutropin AQ NuSpin 20 (somatropin (rDNA origin) injection} 20 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0076-01

September 20, 2012 Genentech Inc 10,306 syringes units

FDA Drug Class II Terminated

Nutropin AQ NuSpin 10 (somatropin (rDNA origin) injection} 10 mg/ 2mL Genentech, South San Francisco, CA 94080, NDC#50242-0074-01

September 20, 2012 Genentech Inc 12,791 syringes units

FDA Drug Class I Terminated

SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873

September 20, 2012 Globe All Wellness, LLC 40,400 bottles units

FDA Drug Class III Terminated

Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand A

September 20, 2012 Sandoz Incorporated 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons units

FDA Drug Class II Terminated

UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Apple-cleani, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403

September 17, 2012 DermaCare, Inc. 25,956 bottles units

FDA Drug Class II Terminated

UP & UP brand, kid's foaming hand sanitizer, alcohol free, 99.9% effective against germs, Sweet s'melon, 6.7FL oz (200mL), Distributed by Target Corp., Minneapollis, MN 55403

September 17, 2012 DermaCare, Inc. 43,272 bottles units

FDA Drug Class III Terminated

Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,

September 12, 2012 Sandoz Incorporated 43,060 x 90 count bottles units

FDA Drug Class III Terminated

Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92

September 12, 2012 Sandoz Incorporated 41,761bottles. units

FDA Drug Class I Ongoing

HYDROCODONE BITARTRATE and ACETAMINOPHEN TABLETS, USP, 10 mg/500 mg, 100-count bottle, Rx only, Mfg. for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-3888-21

September 10, 2012 Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals 14,445 bottles units

FDA Drug Class II Terminated

Orajel Kids My Way! Anticavity Fluoride (sodium fluoride) toothpaste, 0.24%, 3 oz (85 g) pump, Church & Dwight Col, Inc., Princeton, NJ 08543; UPC 3 10310 32370 7.

September 6, 2012 Church & Dwight Inc 42,768 pumps units

FDA Drug Class II Terminated

Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom

September 5, 2012 F. Hoffmann-LaRoche Ltd. 42010 vials units

FDA Drug Class II Terminated

CVS Pharmacy Fiber Capsules for Regularity, Dietary Fiber Supplement, 100 Capsules per bottle, Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895 www.cvs.com UPC 0-50428-07739-9

September 4, 2012 Raritan Pharmaceuticals, Inc. 16,848 bottles units

FDA Drug Class II Terminated

Best Choice Health Care, Psyllium Fiber Supplement, 100% natural Psyllium Fiber Laxative, 100 capsules per bottle, Proudly Distributed by: Valu Merchandisers, Co., Kansas City, KS 06106, UPC 0-70038-6

September 4, 2012 Raritan Pharmaceuticals, Inc. 2160 bottles units

FDA Drug Class II Terminated

Wal-Mucil Plus Calcium Fiber Capsules,100% Natural Fiber, 100% Natural Psyllium Seed Husk, Calcium/Dietary Fiber Supplement, 240 Capsules per bottle, Distributed by: Walgreen Co., 200 Wilmot Road, Dee

September 4, 2012 Raritan Pharmaceuticals, Inc. 7,608 bottles units

FDA Drug Class II Terminated

Berkley & Jensen Fiber Capsules, Fiber Laxative/Fiber Supplement, 100% Natural Psyllium Fiber, 400 capsules per bottle, Distributed by: BJWC, 25 Research Drive, Westborough, MA 01581, Made in USA, UPC

September 4, 2012 Raritan Pharmaceuticals, Inc. 3,552 bottles units

FDA Drug Class II Terminated

Equate Fiber Therapy, 100% Natural Psyllium Husk Fiber, Fiber Laxative/Fiber Supplement, 160 capsules per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716, NDC 68163-119-60, UPC 6-

September 4, 2012 Raritan Pharmaceuticals, Inc. 183,141 bottles units

FDA Drug Class II Terminated

Wal-Mucil 100% Natural Fiber, 100% Natural Psyllium Seed Husk, Fiber Laxative/Supplement, a)160 capsules per bottle (item #503663), and b) 320 capsules per bottle (Item #586143), Distributed by: Walgr

September 4, 2012 Raritan Pharmaceuticals, Inc. 56,808 bottles units

FDA Drug Class III Terminated

Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC 15338-211-30

September 4, 2012 Apace KY LLC 81,516 bottles units

FDA Drug Class II Terminated

Leader Fiber Capsules, 100% Natural Psyllium Fiber Laxative, Dietary Fiber Supplement, Relieves Constipation, Restores Regularity, 100 capsules per bottle, Distributed by: Cardinal Health, Dublin, OH

September 4, 2012 Raritan Pharmaceuticals, Inc. 2,988 bottles units

FDA Drug Class II Terminated

Up&Up Psyllium Fiber Supplement, 100% natural psyllium husk, Fiber Therapy for Regularity/Fiber Supplement, 160 capsules per bottle, Distributed by: Target Corp., Minneapolis, MN 55403, Made in USA,

September 4, 2012 Raritan Pharmaceuticals, Inc. 48,120 bottles units

FDA Drug Class II Terminated

Simply Right Healthcare Fiber Capsules, 100% Natural Psyllium Fiber, Fiber Supplement, Fiber Laxative for Regularity, 400 capsules per bottle, Distributed by: SAM'S West, Inc., Bentonville, AR 72716,

September 4, 2012 Raritan Pharmaceuticals, Inc. 46,104 bottles units

FDA Drug Class II Terminated

Premier Value Fiber Plus Calcium Supplement Capsules, 120 capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton, FL, UPC 8-40986-01987-6

September 4, 2012 Raritan Pharmaceuticals, Inc. 96 bottles units

FDA Drug Class II Terminated

DRxChoice Fiber Capsules, 25 capsules per bottle, Psyllium Husk Fiber, Mfg. by Raritan Pharmaceuticals, East Brunswick, NJ, UPC 3-68163-11925-1.

September 4, 2012 Raritan Pharmaceuticals, Inc. 17,136 bottles units

FDA Drug Class II Terminated

Premier Value Fiber Capsules, Fiber Capsules, 100% Natural Psyllium Fiber, Relieves Constipation, Restores Regularity, 160 Capsules per bottle, Distributed by: Chain Drug Consortium, LLC, Boca Raton,

September 4, 2012 Raritan Pharmaceuticals, Inc. 1,440 bottles units

FDA Drug Class I Terminated

0.9% Sodium Chloride Injection, USP, 100 mL flexible container, Rx only, Hospira, Inc. Lake Forest, IL 60045 --- NDC 0409-7984-23

August 31, 2012 Hospira, Inc. 264,432 bags units

FDA Drug Class II Terminated

Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 50 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409

August 29, 2012 Hospira, Inc. 148,630 vials units

FDA Drug Class I Terminated

BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Diluent manufactured by: Luitpold Pharmaceuticals, Inc. Shirley, N

August 29, 2012 Bristol-myers Squibb Company 31,481 kits units

FDA Drug Class II Terminated

Atrovent HFA Inhalation Aerosol, (ipratropium bromide) 12.9 grams, 200 metered actuations, Rx only, Packaged Exclusively by: Dispensing Solutions, Inc., Santa Ana, CA --- NDC 68258-8952-01, DSI produc

August 28, 2012 Dispensing Solutions, Inc 18 Inhalers units

FDA Drug Class II Terminated

I-C Drops, Eye Cleansing Agent, 15 ml ASN/Maxam P.O. Box 1277 Hood River, OR 97031

August 28, 2012 James G. Cole, Inc. 253 bottles units