Caraco Pharmaceutical Laboratories Ltd.

FDA Drug Class II Terminated

Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756-294-88) and b) 500-count bottles (NDC 62756-294-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, A

June 26, 2014 Caraco Pharmaceutical Laboratories Ltd. a) 43,585 bottles; b) 296,968 bottles units

FDA Drug Class II Terminated

Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756-293-88) and b) 500-count bottles (NDC 62756-293-13), Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, A

June 26, 2014 Caraco Pharmaceutical Laboratories Ltd. a) 70,152 bottles; b) 43,525 bottles units

FDA Drug Class II Terminated

Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged in 30 Count and 90 Count Bottles. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detro

June 12, 2014 Caraco Pharmaceutical Laboratories Ltd. 26,530 30-Count Bottles; 14,597 90-Count Bottles units

FDA Drug Class II Terminated

Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40

April 9, 2014 Caraco Pharmaceutical Laboratories Ltd. 200 vials units

FDA Drug Class III Terminated

Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle, OTC, Manufactured by Sun Pharma, Gujarat, India, Distributed Chain Drug Consortium, Boca Raton, FL, NDC 47335-344-83

April 9, 2014 Caraco Pharmaceutical Laboratories Ltd. 47,813 bottles units

FDA Drug Class III Terminated

Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83

April 9, 2014 Caraco Pharmaceutical Laboratories Ltd. 128,363 bottles units

FDA Drug Class II Terminated

Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), R

March 20, 2014 Caraco Pharmaceutical Laboratories Ltd. 91,777 bottles units

FDA Drug Class II Terminated

Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30-count bottles (NDC 41616-758-83, UPC 3 41616 75883 2); and b) 90-count bottles (NDC 41616-758-81, UPC 3 41616 75881 8), Rx

March 20, 2014 Caraco Pharmaceutical Laboratories Ltd. 160,105 bottles units

FDA Drug Class II Terminated

Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202. Manufactured by: Sun Pharmaceutica

January 29, 2014 Caraco Pharmaceutical Laboratories Ltd. 7005 bottles units

FDA Drug Class II Terminated

Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bottles, Manufactured by: Sun Pharmaceutical Inc. Ltd, Andheri (East) Mumbai-400 059, India, Distributed by: Caraco Pharmaceuti

January 28, 2014 Caraco Pharmaceutical Laboratories Ltd. 2528 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

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

August 21, 2012 Caraco Pharmaceutical Laboratories Ltd. a) 2424 Cartons b) 2675 Cartons units