Sandoz, Inc

FDA Drug Class II Ongoing

Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Prod

September 5, 2025 Sandoz, Inc 6 vials units

FDA Drug Class II Ongoing

Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princeton, NJ, NDC# 0781-61

August 13, 2025 Sandoz, Inc 1,680 bottles units

FDA Drug Class I Ongoing

Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0

June 27, 2025 Sandoz, Inc 208,300 vials units

FDA Drug Class I Ongoing

Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0

June 27, 2025 Sandoz, Inc unknown units

FDA Drug Class II Terminated

Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.

March 21, 2022 Sandoz, Inc 7908 bottles(790,800 extended release tablets) units

FDA Drug Class I Completed

Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 085

November 17, 2021 Sandoz, Inc 45,036 cartons units

FDA Drug Class II Terminated

Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60

April 21, 2020 Sandoz, Inc 17,500 units units

FDA Drug Class III Terminated

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ

October 17, 2019 Sandoz, Inc 346,929 bottles units

FDA Drug Class III Terminated

Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratori

October 17, 2019 Sandoz, Inc 346,929 bottles units

FDA Drug Class III Terminated

Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540,

October 17, 2019 Sandoz, Inc 76,644 bottles units

FDA Drug Class II Terminated

Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60

September 23, 2019 Sandoz, Inc 100,314 bottles units

FDA Drug Class II Terminated

Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31

September 23, 2019 Sandoz, Inc 136,788 bottles units

FDA Drug Class II Terminated

Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05

September 23, 2019 Sandoz, Inc 13,130 bottles units

FDA Drug Class III Terminated

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC

November 2, 2018 Sandoz, Inc 23053 bottles units

FDA Drug Class II Terminated

Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00

November 2, 2018 Sandoz, Inc 7817 bottles units

FDA Drug Class II Terminated

Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01

November 2, 2018 Sandoz, Inc 18,832 bottles units

FDA Drug Class II Terminated

Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00

November 2, 2018 Sandoz, Inc 5100 bottles units

FDA Drug Class III Terminated

Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz

November 2, 2018 Sandoz, Inc 14366 bottles units

FDA Drug Class II Terminated

Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00

November 2, 2018 Sandoz, Inc 1550 bottles units

FDA Drug Class II Ongoing

Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia fo

November 1, 2018 Sandoz, Inc 170 HDPE bottles units

FDA Drug Class III Terminated

Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc.

September 25, 2017 Sandoz, Inc 13,435 shrink wrap packs units

FDA Drug Class III Terminated

Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20

April 26, 2017 Sandoz, Inc 4,464 bottles units

FDA Drug Class II Terminated

Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana, - SI-1526, Slovenia --- NDC 0781-5635-31

February 10, 2017 Sandoz, Inc N/A units

FDA Drug Class II Terminated

Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vac

February 2, 2017 Sandoz, Inc 157,922 cartons units

FDA Drug Class III Terminated

Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz

December 13, 2016 Sandoz, Inc a) 10,200 bottles; b) 300 bottles units

FDA Drug Class II Terminated

L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz

November 9, 2016 Sandoz, Inc 18,751 vials units

FDA Drug Class II Terminated

L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, In

November 9, 2016 Sandoz, Inc 33,624 vials units

FDA Drug Class III Terminated

Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 04

October 19, 2016 Sandoz, Inc 139,430 vials units

FDA Drug Class II Terminated

Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ

August 24, 2016 Sandoz, Inc 32,099 cartons units

FDA Drug Class II Terminated

Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, C

August 24, 2016 Sandoz, Inc 42,740 cartons (24 count carton from 7 total lots) units

FDA Drug Class II Terminated

Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), R

August 24, 2016 Sandoz, Inc a) 1,584 cartons; b) 62,170 vials units

FDA Drug Class III Terminated

Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01

May 25, 2016 Sandoz, Inc 3,048 bottles ( 304,800 tablets) units

FDA Drug Class III Terminated

Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01

May 2, 2016 Sandoz, Inc N/A units

FDA Drug Class III Terminated

Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01

May 2, 2016 Sandoz, Inc 78,606 bottles units

FDA Drug Class III Terminated

Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sand

December 31, 2015 Sandoz, Inc 277,267 bottles units

FDA Drug Class III Terminated

Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Be

April 15, 2015 Sandoz, Inc 1,023,430 units units

FDA Drug Class III Terminated

candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92

October 2, 2014 Sandoz, Inc 6,336 bottles units

FDA Drug Class III Terminated

Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.

July 11, 2014 Sandoz, Inc 781,000 extended release tablets units

FDA Drug Class II Terminated

Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540. NDC 0781-5439-20.

May 22, 2014 Sandoz, Inc 22,818 Bottles units

FDA Drug Class III Terminated

Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC a) 0185-0128-01, b) 0185-0128-05

November 6, 2013 Sandoz, Inc 11,496 bottles (100 count) and 62 bottles (500 count) units

FDA Drug Class II Terminated

Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,

October 11, 2013 Sandoz, Inc 2,491 bottles of 100 tablets each units

FDA Drug Class II Terminated

Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92

October 9, 2013 Sandoz, Inc 692 bottles (90 count) units