co_sos
1 records
courtlistener_docket
4 records
PHARMACOSMOS HOLDING A/S v. SANDOZ INC.
2026-05-01
Federal docket 2:26-cv-04948 (njd); matched party 'SANDOZ INC.'
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OPUS GENETICS, INC. v. SANDOZ INC.
2026-04-29
Federal docket 3:26-cv-04811 (njd); matched party 'SANDOZ INC.'
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Sandoz Inc. v. Kesin Pharma Corporation
2024-11-21
Federal docket 1:24-cv-08877 (nysd); matched party 'Sandoz Inc.'
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Sandoz Inc. v. Kesin Pharma Corporation
2024-11-21
Federal docket 1:24-cv-08877 (nysd); matched party 'Sandoz Inc.'
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EPA (Environmental Protection Agency)
1 records
epa_echo
2 records
fda
58 records
FDA Drug Recall: Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Ste
2025-09-24
Class II — cGMP deviations: Temperature excursion during transportation.
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FDA Drug Recall: Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ea
2025-09-17
Class II — Temperature Abuse
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FDA Drug Recall: Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Int
2025-07-09
Class I — Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained ...
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FDA Drug Recall: Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million
2025-07-09
Class I — Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
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FDA Drug Recall: Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets,
2022-04-13
Class II — CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
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FDA Drug Recall: Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automa
2021-12-08
Class I — Temperature Abuse; temperature excursion during shipping
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FDA Drug Recall: Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 an
2020-05-13
Class II — Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
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FDA Drug Recall: Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx On
2019-11-06
Class III — Labeling: Incorrect or missing package insert.
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FDA Drug Recall: Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Steril
2019-11-06
Class III — Labeling: Incorrect or missing package insert.
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FDA Drug Recall: Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the U
2019-11-06
Class III — Labeling: Incorrect or missing package insert.
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FDA Drug Recall: Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured
2019-10-16
Class II — CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
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FDA Drug Recall: Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured
2019-10-16
Class II — CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
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FDA Drug Recall: Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured
2019-10-16
Class II — CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
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FDA Drug Recall: Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 10
2018-12-05
Class II — CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level o...
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FDA Drug Recall: Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a)
2018-11-21
Class III — Cross Contamination with Other Products
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FDA Drug Recall: Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count botto
2018-11-21
Class III — Cross Contamination with Other Products
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FDA Drug Recall: Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured
2018-11-21
Class II — Cross Contamination with Other Products
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FDA Drug Recall: Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured
2018-11-21
Class II — Cross Contamination with Other Products
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FDA Drug Recall: Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed
2018-11-21
Class II — Cross Contamination with Other Products
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FDA Drug Recall: Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured b
2018-11-21
Class II — Cross Contamination with Other Products
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FDA Drug Recall: Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles
2018-04-25
Class III — Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
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FDA Drug Recall: Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) p
2017-10-04
Class III — Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
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FDA Drug Recall: Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-
2017-07-12
Class III — Cross Contamination With Other Product: Imipramine
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FDA Drug Recall: Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count b
2017-06-07
Class III — Subpotent Drug; Clavulanic Acid
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FDA Drug Recall: Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only
2017-03-15
Class II — Failed Dissolution Specifications
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FDA Drug Recall: Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC
2017-03-01
Class II — Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The p...
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FDA Drug Recall: Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 078
2017-01-25
Class III — Subpotent Drug: out of specification results for assay test.
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FDA Drug Recall: Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured
2017-01-04
Class II — Failed dissolution specification: recalled due to an out of specification dissolution result of 40% (Specification: NLT 80%)
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FDA Drug Recall: Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or
2016-11-30
Class III — Labeling: Missing Label
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FDA Drug Recall: L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package V
2016-11-23
Class II — Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
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FDA Drug Recall: L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Do
2016-11-23
Class II — Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.
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FDA Drug Recall: Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack,
2016-11-16
Class II — Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
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FDA Drug Recall: Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL
2016-09-28
Class II — Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
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FDA Drug Recall: Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-0
2016-09-28
Class II — Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that product sterility may be compromised.
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FDA Drug Recall: Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactu
2016-06-29
Class III — Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
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FDA Drug Recall: Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactu
2016-06-29
Class III — Failed Impurities/Degradation Specifications:Out of specification result for a known impurity obtained during testing.
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FDA Drug Recall: Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sando
2016-06-22
Class III — Labeling: Incorrect or Missing Package Insert
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FDA Drug Recall: Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90
2016-02-17
Class III — Failed Impurities/Degradation Specifications; 9 month stability timepoint
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FDA Drug Recall: Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 bliste
2015-06-10
Class III — Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
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FDA Drug Recall: Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz
2014-12-17
Class III — Labeling: Illegible Label: Sandoz Inc. is recalling of one lot of Fluoxetine Capsules due to an illegible logo on the capsule.
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FDA Drug Recall: candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured
2014-12-10
Class III — Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.
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FDA Drug Recall: Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton,
2014-08-06
Class II — Presence of Foreign Substance; tablets may contain stainless steel metal particulates
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FDA Drug Recall: Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC
2014-07-30
Class III — Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
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FDA Drug Recall: Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactu
2014-06-04
Class II — Presence of Foreign Substance: Presence of stainless steel particles.
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FDA Drug Recall: Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 T
2014-01-08
Class II — Subpotent; Hydrochlorothiazide at the 9 month time point.
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FDA Drug Recall: Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in
2014-01-01
Class II — Cross Contamination with Other Products: findings of carryover of trace amounts of a previously manufactured product fluvastatin
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FDA Drug Recall: Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle
2013-12-18
Class III — 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.
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FDA Drug Recall: Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactur
2013-11-13
Class II — Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously m...
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FDA Drug Recall: Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle
2013-10-16
Class III — Failed Tablet/Capsule Specifications: Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets, USP, 200mg, due to illegibility of the logo on some tablets.
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FDA Drug Recall: Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Sing
2013-08-14
Class I — Presence of Particulate Matter: Found during examination of retention samples.
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FDA Drug Recall: Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg,
2013-08-14
Class III — Contraceptive tablets out of sequence: Contraceptive tablets out of sequence: Introvale (levonorgestrel and ethinyl estradiol tablets USP 0.15mg/0.03mg) is voluntarily being recalled due t...
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FDA Drug Recall: Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X2
2013-07-24
Class II — Contraceptive Tablets out of Sequence: A placebo tablet was found in a row of active tablets.
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FDA Drug Recall: Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, singl
2013-06-19
Class II — Lack of Assurance of Sterility: Sandoz Inc is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a customer complaint for broken/cracked vials which was confirmed through...
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FDA Drug Recall: Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sand
2013-05-01
Class II — 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.
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FDA Drug Recall: Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blisterc
2013-02-13
Class III — Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.
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FDA Drug Recall: Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufact
2012-10-24
Class III — Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
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FDA Drug Recall: Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx o
2012-09-26
Class III — Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
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FDA Drug Recall: Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx on
2012-09-26
Class III — Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
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fda_adverse
3 records
FDA AE Manufacturer: Sandoz, Inc.
Drug adverse event reporter — Product: CHLORPROMAZINE HYDROCHLORIDE
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ftc_enforcement
1 records
Ciba-Geigy Ltd / Sandoz Ltd
1996-12-16
FTC merger enforcement action FY1997 matter 9610055; matched respondent 'Sandoz Ltd'
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lobbying
7 records
ny_corps
1 records
NY Corp: SANDOZ INC.
2003-07-28
FOREIGN BUSINESS CORPORATION | County: New York | Jurisdiction: Delaware
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