Sandoz Incorporated

FDA Drug Class III Terminated

Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.

April 6, 2018 Sandoz Incorporated 11,680 bottles units

FDA Drug Class III Terminated

Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540

June 16, 2017 Sandoz Incorporated 38,234 bottles units

FDA Drug Class II Terminated

Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10

December 22, 2016 Sandoz Incorporated 96 bottles units

FDA Drug Class III Terminated

Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01

December 5, 2014 Sandoz Incorporated 1,008 bottles units

FDA Drug Class II Terminated

Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10

July 25, 2014 Sandoz Incorporated 1,332 bottles units

FDA Drug Class II Terminated

Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz Inc., Princeton, NJ NDC 0781-2102-01

October 22, 2013 Sandoz Incorporated 12,521 bottles units

FDA Drug Class III Terminated

Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01.

September 25, 2013 Sandoz Incorporated 25,830 bottles units

FDA Drug Class III Terminated

Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios L

August 7, 2013 Sandoz Incorporated 8, 681 unit cartons units

FDA Drug Class II Terminated

Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540,

June 21, 2013 Sandoz Incorporated 10,848 cartons units

FDA Drug Class II Terminated

Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 0

May 30, 2013 Sandoz Incorporated 297,200 vials units

FDA Drug Class I Terminated

Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg

May 20, 2013 Sandoz Incorporated 1,635 vials units

FDA Drug Class II Terminated

Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles.

April 18, 2013 Sandoz Incorporated 8286 x 30 ct, 37108 x 500 ct. bottles units

FDA Drug Class III Terminated

Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Prince

January 22, 2013 Sandoz Incorporated 17,188 cartons containing 3 cards each. 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 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 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