Sandoz Inc

• AzithromycinZithromax, Azasite · 3 products
• Pilocarpine hydrochlorideSalagen, Qlosi · 3 products
• AprepitantEmend, Cinvanti, Aponvie · 3 products
• ClindamycinCleocin Phosphate, Cleocin Hydrochloride, Clindamycin Phoaphate Topical Solution Usp, 1% · 3 products
• Penicillin gPfizerpen · 3 products
• SitagliptinJanuvia, Zituvio, Brynovin · 3 products
• VoriconazoleVfend · 3 products
• PirfenidoneEsbriet · 3 products
• Metolazone3 products
• Brimonidine tartrateAlphagan P, Mirvaso · 3 products
• Neomycin sulfate, polymyxin b sulfate and hydrocortisoneNeomycin and Polymyxin B Sulfates and Hydrocortisone, Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic Suspension, Neomycin and Polymyxin B Sulfates and Hydrocortisone Otic · 3 products
• UstekinumabWezlana, Pyzchiva, Starjemza · 3 products
• DexmedetomidinePrecedex, Dexmedetomidine in Dextrose, Igalmi · 3 products
• Cefazolin3 products
• NintedanibOfev · 2 products
• MesalaminePentasa, Lialda, Mesalamine Rectal · 2 products
• Meropenem2 products
• Sitagliptin and metformin hydrochlorideZituvimet XR, Zituvimet, Janumet · 2 products
• DapagliflozinFarxiga · 2 products
• TropicamideMydriacyl · 2 products
• Ranibizumab-eqrnCimerli, Byooviz, Nufymco · 2 products
• FilgrastimNivestym, Releuko, Neupogen · 2 products
• SomatropinNorditropin, Omnitrope · 2 products
• Glatiramer acetateGlatopa, Copaxone · 2 products
• Cefpodoxime proxetil2 products
• DifluprednateDifluprednate Ophthalmic Emulsion, Durezol · 2 products
• CiprofloxacinCiprofloxacin in Dextrose, Cipro, Ciloxan · 2 products
• Acetaminophen2 products
• SugammadexBridion · 2 products
• BrinzolamideAzopt · 2 products
• SuccinylcholineAnectine, Quelicin · 2 products
• Caspofungin acetateCancidas · 2 products
• FulvestrantCligavyx, Faslodex · 2 products
• FluvastatinLescol XL · 2 products
• TopotecanHycamtin · 2 products
• OlanzapineZyprexa, Zyprexa Zydis, Olanzapine Intramuscular · 2 products
• Ciprofloxacin hydrochloride and hydrocortisoneCipro Hc · 2 products
• LidocaineXylocaine Mpf, Xylocaine, Lidocaine Viscous · 2 products
• Chlorpromazine hydrochloride2 products
• PrucaloprideMotegrity · 2 products
• Hydroxyzine2 products
• Mycophenolate mofetilCellcept, Myhibbin · 2 products
• LinezolidZyvox · 2 products
• DenosumabBomyntra, Bildyos, Xtrenbo · 2 products
• Palonosetron hydrochloridePosfrea · 1 product
• Eribulin mesylateHalaven · 1 product
• Arsenic trioxideTrisenox · 1 product
• Edaravone1 product
• SevofluraneUltane, Sevoflurane, (Volatile for Inhalation), Sojourn · 1 product
• MoxifloxacinVigamox · 1 product
• AfliberceptZaltrap, Pavblu, Eylea Hd · 1 product
• TobramycinTobramycin Inhalation Solution Pak, Tobi, Tobi Podhaler · 1 product
• Tamsulosin hydrochloride1 product
• Cefdinir1 product
• Rocuronium bromide1 product
• FidaxomicinDificid · 1 product
• MacitentanOpsumit · 1 product
• Cromolyn sodiumGastrocrom · 1 product
• Triamterene and hydrochlorothiazide1 product
• Butalbital, aspirin, and caffeine1 product
• Ferumoxytol (ferumoxytol non-stoichiometric magnetite)Feraheme · 1 product
• Pantoprazole sodiumProtonix I.V., Protonix Delayed-Release, Pantoprazole Sodium I.V. · 1 product
• AzacitidineOnureg, Vidaza · 1 product
• Ferric carboxymaltoseInjectafer · 1 product
• Bromocriptine mesylateCycloset · 1 product
• Entacapone1 product
• Ciprofloxacin and dexamethasone1 product
• Brimonidine tartrate and timolol maleateCombigan · 1 product
• DiclofenacZipsor, Lofena, Cambia · 1 product
• Proparacaine hydrochlorideAlcaine · 1 product
• Cyclopentolate hydrochlorideCyclogyl · 1 product
• Bivalirudin1 product
• Nitrofurantoin (monohydrate/macrocrystals)Macrobid, Nitrofurantoin Monohydrate Macrocrystalline, Nitrofurantoin Mono · 1 product
• Natalizumab-sztnTyruko, Tysabri · 1 product
• LatanoprostIyuzeh, Xalatan, Xelpros · 1 product
• Gentamicin sulfateGentak · 1 product
• Norepinephrine bitartrateLevophed · 1 product
• Dorzolamide hydrochloride1 product
• Trifluridine1 product
• Prednisolone acetatePred Forte, Pred Mild · 1 product
• Tobramycin and dexamethasoneTobradex St, Tobradex · 1 product
• DocetaxelBeizray, Docivyx · 1 product
• Isoniazid1 product
• Ephedrine sulfateEmerphed Pfs, Akovaz, Emerphed · 1 product
• MontelukastSingulair · 1 product
• WaterSterile Water, Bacteriostatic Water, Insulin Diluting Medium for Garzulys · 1 product
• TafluprostZioptan · 1 product
• Azelastine hydrochloride1 product
• Pegfilgrastim-cbqvUdenyca, Stimufend, Neulasta · 1 product
• CladribineMavenclad · 1 product
• Ketorolac tromethamineAcuvail, Sprix, Ketrolac Tromethamine · 1 product
• GatifloxacinZymaxid · 1 product
• CosyntropinCortrosyn · 1 product
• DesfluraneSuprane · 1 product
• FluorometholoneFml, Fml Forte · 1 product
• BimatoprostLumigan, Latisse, Durysta · 1 product
• Betaxolol hydrochlorideBetoptic S · 1 product
• Travoprost ophthalmic solutionTravatan Z, Idose Tr, Travoprost Ophthalmic Soluton · 1 product
• Amoxicillin and clavulanate potassium (amoxicillin / amoxicillin sodium / clavulanate potassium)1 product
• Pyridostigmine bromideMestinon, Pryidostigmine Bromide, Regonol · 1 product
• TigecyclineTygacil · 1 product
• Azelaic acidFinacea Foam, Azelex · 1 product
• Ascorbic acid, vitamin a palmitate, cholecalciferol, thiamine hydrochloride, RIBOFLAVIN-5 phosphate sodium, pyridoxine hydrochloride, niacinamide, dexpanthenol, alpha-tocopherol acetate, vitamin K1, folic acid, biotin, cyanocobalaminPediatric Infuvite Multiple Vitamins · 1 product
• Dorzolamide hydrochloride and timolol maleateCosopt, Dorzolamide Hydrochloride Timolol Maletae, Cosopt Pf · 1 product
• Carteolol hydrochloride1 product
• Polymyxin b sulfate and trimethoprim sulfate1 product
• NelarabineArranon · 1 product
• DigoxinLanoxin · 1 product
• PaclitaxelPaclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), Paclitaxel 100mg Per Vial, Abraxane · 1 product
• Albuterol sulfateVentolin HFA, Albuterol Sulate HFA, Proair Respiclick · 1 product
• Orphenadrine citrate1 product
• Apraclonidine hydrochloride ophthalmic solutionIopidine 1% · 1 product
• Zoledronic acidReclast · 1 product

2022

1. April 13, 2022 · Class II · Terminated · D-1024-2022 · Albuterol sulfate

   cGMP deviations: Temperature abuse

   Albuterol Sulfate Inhalation Aerosol HFA 90 mcg, with Dose Indicator, 200 metered inhalations, Rx only, Distributed by: Sandoz Inc., NDC 0781-7296-85

2. April 13, 2022 · Class II · Terminated · D-1025-2022 · Amoxicillin

   cGMP deviations: Temperature abuse

   Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0781-2613-01

3. April 13, 2022 · Class II · Terminated · D-1102-2022 · Neomycin sulfate, polymyxin b sulfate and dexamethasone

   cGMP deviations: Temperature abuse

   Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, 3.5 g tube, Rx only MFG: Sandoz, NDC 61314-631-36

4. April 13, 2022 · Class II · Terminated · D-1046-2022 · Hydroxyzine

   cGMP deviations: Temperature abuse

   HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01

5. March 21, 2022 · Class II · Terminated · D-0753-2022 · Orphenadrine citrate

   CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.

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

6. January 26, 2022 · Class II · Terminated · D-0179-2024 · Enoxaparin sodium

   CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

   Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69

7. January 26, 2022 · Class II · Terminated · D-0166-2024 · Amoxicillin

   CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

   AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20

2021

1. March 15, 2021 · Class II · Terminated · D-0564-2021 · Cefazolin

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   Cefazolin for Injection, USP 1 gram per vial Rx Only Single-use Vial Sterile Manufactured in Austria by Sandoz GmbH for Sandoz, Inc., Princeton, NJ 08540, NDC 0781-3451-70

2020

1. October 6, 2020 · Class III · Terminated · D-0042-2021 · Desflurane

   DEFECTIVE CONTAINER: Desflurane Liquid for Inhalation 240 mL may be leaking.

   Desflurane, USP Liquid for Inhalation, 240 mL, Rx Only, Manufactured by: Shanghai Hengrui Pharmaceutical Co., Ltd., Shanghai, 200245, China for Sandoz Inc. Princeton, NJ 08540, NDC 0781-6172-22

2019

1. October 17, 2019 · Class III · Terminated · D-0161-2020 · Bimatoprost

   Labeling: Incorrect or missing package insert.

   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 Laboratories, Inc. Fort Worth,

2. October 17, 2019 · Class III · Terminated · D-0163-2020 · Gatifloxacin

   Labeling: Incorrect or missing package insert.

   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, Product of India, ND

3. October 17, 2019 · Class III · Terminated · D-0162-2020 · Neomycin sulfate, polymyxin b sulfate and dexamethasone

   Labeling: Incorrect or missing package insert.

   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 08540, NDC 61314-63

2018

1. November 2, 2018 · Class II · Terminated · D-0258-2019 · Isosorbide dinitrate

   Cross Contamination with Other Products

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

2. November 2, 2018 · Class III · Terminated · D-0257-2019 · Nitrofurantoin (monohydrate/macrocrystals)

   Cross Contamination with Other Products

   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 Inc. Princeton, NJ 0

2017

1. September 25, 2017 · Class III · Terminated · D-1179-2017 · Ampicillin

   Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.

   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., Princeton, NJ 0854

2. June 16, 2017 · Class III · Terminated · D-0943-2017 · Amitriptyline hydrochloride

   Cross Contamination With Other Product: Imipramine

   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

3. April 26, 2017 · Class III · Terminated · D-0868-2017 · Amoxicillin and clavulanate potassium (amoxicillin / clavulanate)

   Subpotent Drug; Clavulanic Acid

   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

4. March 22, 2017 · Class III · Terminated · D-0679-2017 · Pilocarpine hydrochloride

   Failed Impurities/Degradation Specifications.

   Pilocarpine Hydrochloride Ophthalmic Solution 4% , packaged in 15 mL bottles, Rx Only, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 Sandoz Princeton, NJ 08540, NDC 61314-206-15

2014

1. July 25, 2014 · Class II · Terminated · D-1509-2014 · Alprazolam

   Presence of Foreign Substance; tablets may contain stainless steel metal particulates

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

2. July 11, 2014 · Class III · Terminated · D-1445-2014 · Orphenadrine citrate

   Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

   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.

3. May 22, 2014 · Class II · Terminated · D-1350-2014 · Cefpodoxime proxetil

   Presence of Foreign Substance: Presence of stainless steel particles.

   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.

2013

1. November 6, 2013 · Class III · Terminated · D-341-2014 · Bumetanide

   Failed Moisture Limit; Out of Specification (OOS) results were obtained for moisture content during stability testing at the 12 month time point, controlled room temperature conditions.

   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

2. October 22, 2013 · Class II · Terminated · D-383-2014 · Tacrolimus

   Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin

   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

3. April 18, 2013 · Class II · Terminated · D-268-2013 · Amoxicillin

   Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.

   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.

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).