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Glenmark Pharmaceuticals Inc., USA FDA Recalls
124 recalls on file across drugs, 2 of them Class I and 105 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distributed by: Glenmark Pharmaceuticals Inc., USA,Class IIJul 23, 2026CGMP Deviations: Product quality complaints concerning abnor |
| Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Class IIMay 27, 2026Failed Impurities/Degradation Specifications: This recall is |
| Ondansetron Orally Disintegrating Tablets, USP, 4mg, 30 Tablets (3 blistercards each containing 10 tablets), Rx only, MaClass IIDec 30, 2025Defective container: Preferred Pharmaceuticals received a le |
| Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-87Class IIINov 21, 2025Cross Contamination with Other Products: Testing of reserve |
| Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya PradClass IIINov 18, 2025Cross Contamination with Other Products |
| Azelaic Acid Gel, 15%, 50 grams, For Topical Use Only, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited ColvalClass IISep 17, 2025CGMP Deviations: Market complaints received for gritty textu |
| Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 BlisterClass IISep 3, 2025Failed Impurities/Degradation Specifications |
| Theophylline extended-release tablets 400mg, 100-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals LimiteClass IIAug 8, 2025Failed Dissolution Specifications: Failure results (above) w |
| Carvedilol Tablets, USP, 25 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-BardezClass IIAug 7, 2025CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carve |
| Carvedilol Tablets, USP, 12.5 mg, 500-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd, Colvale-BardClass IIAug 7, 2025CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carve |
| Carvedilol Tablets, USP, 3.125 mg, Packaged as: a)500-count bottle, NDC 68462-162-05; b) 100-count bottle, NDC 68462-162Class IIAug 7, 2025CGMP Deviations: Presence of a nitrosamine, N-Nitroso Carve |
| Carvedilol Tablets, USP, 12.5 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot Class IIAug 6, 2025CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 |
| Carvedilol Tablets, USP, 25 mg, 500 Tablets per carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot NoClass IIAug 6, 2025CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 |
| Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Class IIIMay 19, 2025Failed Impurities/Degradation Specifications: Out of Specifi |
| Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark PhClass IIMay 15, 2025OOS results reported for the Dissolution (by UV) test. |
| Ranolazine Extended-Release Tablets 1000mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals LimiteClass IIMar 13, 2025CGMP Deviations |
| Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., DisClass IIMar 13, 2025CGMP Deviations |
| Metformin Hydrochloride Extended-Release Tablets 1000mg, 90-count bottle. Manufactured by: Glenmark Pharmaceuticals LimiClass IIMar 13, 2025CGMP Deviations |
| Gabapentin Tablets 600mg, 500-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadhClass IIMar 13, 2025CGMP Deviations |
| Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark PharmaceuClass IIMar 13, 2025CGMP Deviations |
| Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur,Class IIMar 13, 2025CGMP Deviations |
| Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, PClass IIMar 13, 2025CGMP Deviations |
| Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, PithaClass IIMar 13, 2025CGMP Deviations |
| Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), ManufacClass IIMar 13, 2025CGMP Deviations |
| Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadhyaClass IIMar 13, 2025CGMP Deviations |
| Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd byClass IIMar 13, 2025CGMP Deviations |
| Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadhyaClass IIMar 13, 2025CGMP Deviations |
| Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadhClass IIMar 13, 2025CGMP Deviations |
| Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Class IIMar 13, 2025CGMP Deviations |
| Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadClass IIMar 13, 2025CGMP Deviations |
| Naproxen Sodium Tablets, USP, 550mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, PithClass IIMar 13, 2025CGMP Deviations |
| Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx OnClass IIMar 13, 2025CGMP Deviations |
| Pravastatin Sodium Tablets, 20mg, a).500-count bottle (NDC# 68462-196-05), b). 90-count bottle (NDC# 68462-196-90), Rx oClass IIMar 13, 2025CGMP Deviations |
| Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, PiClass IIMar 13, 2025CGMP Deviations |
| Pravastatin Sodium Tablets, USP, 80mg, a).90-count bottle (16714-570-01), b). 500-count bottle (NDC 16714-570-02), Rx OnClass IIMar 13, 2025CGMP Deviations |
| Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadhyClass IIMar 13, 2025CGMP Deviations |
| Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, PClass IIMar 13, 2025CGMP Deviations |
| Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Class IIMar 13, 2025CGMP Deviations |
| Solifenacin Succinate Tablets 5mg, a.) 30-count bottle (NDC# 68462-386-30) b.) 90-count bottle (NDC# 68462-386-90), Rx OClass IIMar 13, 2025CGMP Deviations |
| Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, ManufactuClass IIMar 13, 2025CGMP Deviations |
| Frovatriptan Succinate Tablets 2.5mg, 9-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, PithamClass IIMar 13, 2025CGMP Deviations |
| Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packClass IIMar 13, 2025CGMP Deviations |
| Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, PiClass IIMar 13, 2025CGMP Deviations |
| Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadClass IIMar 13, 2025CGMP Deviations |
| Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, PithampurClass IIMar 13, 2025CGMP Deviations |
| Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadhyClass IIMar 13, 2025CGMP Deviations |
| Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadhyClass IIMar 13, 2025CGMP Deviations |
| Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark PharmaceutClass IIMar 13, 2025CGMP Deviations |
| Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark PharClass IIMar 13, 2025CGMP Deviations |
| Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, MemClass IIMar 13, 2025CGMP Deviations |
| Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, MadhyClass IIMar 13, 2025CGMP Deviations |
| Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark PharmaceuticaClass IIMar 13, 2025CGMP Deviations |
| Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, PithampurClass IIMar 13, 2025CGMP Deviations |
| Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur,Class IIMar 13, 2025CGMP Deviations |
| chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark PharmaceutClass IIMar 11, 2025CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromaz |
| Carvedilol Tablets USP 6.25 mg, a.)100-count bottle (NDC 68462-163-01), b.) 500-count bottle (NDC 68462-163-05) Rx Only,Class IIFeb 28, 2025CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity |
| Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured fClass IIFeb 28, 2025CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity |
| Carvedilol Tablets USP 3.125mg Tablets a.)100-count bottle (NDC 68462-162-01), b.) 500-count bottle (NDC 68462-162-05),Class IIFeb 28, 2025CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity |
| Carvedilol Tablets USP 12.5 mg, 500-Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured Class IIFeb 28, 2025CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity |
| Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,Class IIJan 29, 2025CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity |
| Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, MClass IIJan 29, 2025CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity |
| Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,Class IIJan 29, 2025CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity |
| Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,Class IIJan 29, 2025CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity |
| Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, MClass IIJan 29, 2025CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity |
| Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, MClass IIJan 29, 2025CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity |
| Atomoxetine Capsules, USP, 60 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,Class IIJan 29, 2025CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity |
| Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, MClass IIJan 29, 2025CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity |
| Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,Class IIJan 29, 2025CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity |
| Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Class IIJan 29, 2025CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity |
| Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, MClass IIJan 29, 2025CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity |
| Atomoxetine Capsules, USP, 40 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, MClass IIJan 29, 2025CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity |
| Atomoxetine Capsules, USP, 100 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USAClass IIJan 29, 2025CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity |
| Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,Class IIJan 29, 2025CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity |
| Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, ManufacturClass IIJan 22, 2025CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) wer |
| Carvedilol Tablets, USP, 25 mg, Rx only, a)500 Tablets, NDC 68462-165-05; b) 100 Tablets, NDC 68462-165-01, ManufacturedClass IIJan 22, 2025CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) wer |
| chlorproMAZINE Hydrochloride Tablets, USP, 10mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals IClass IIDec 11, 2024CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity |
| chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottle, RX only, Manufactured for: Glenmark Pharmaceuticals Class IIDec 11, 2024CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity |
| Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark PharmacClass IINov 1, 2024cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem i |
| Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, ManuClass IINov 1, 2024cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem i |
| Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd Class IINov 1, 2024cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem i |
| Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd fClass IINov 1, 2024cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem i |
| Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark PharmacClass IINov 1, 2024cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem i |
| Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd Class IINov 1, 2024cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem i |
| Ciclopirox Gel 0.77%, For Dermatologic Use Only, Not for Use in Eyes, Rx Only, a) 30 gm Tube, NDC 68462-0455-35; b) 45 gClass IIISep 30, 2024Defective Container: Firm received complaints of broken tube |
| Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bClass IISep 24, 2024Defective Delivery System: The dip tube is clogged causing t |
| Mupirocin Ointment, USP, 2%, 22 g, Rx only, Manufactured by: Glenmark Pharmaceuticals, Ltd., Colvale-Bardez, Goa 403513,Class IIAug 30, 2024Subpotent Drug |
| Indomethacin Extended-Release Capsules, USP, 75 mg, packaged in a) 60-count bottle (NDC 68462-325-60) and b) 90-count bClass IIJul 31, 2024Failed Dissolution Specifications: below specification resul |
| Glenmark, Azelaic Acid Gel, 15 %, 50 grams, Rx only, Manufactured by: Glenmark Pharmaceuticals Limited, Colvale-Bardez, Class IIJul 22, 2024CGMP Deviations |
| Pravastatin Sodium Tablets, USP 80mg, packaged in a) 90-count bottle, NDC 68462-198-90; b) 500-count bottle, NDC 68462-1Class IIJun 28, 2024Failed Dissolution Specifications: results below specificati |
| Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: GlenmaClass IIMay 30, 2024CGMP Deviations |
| Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: GlenmaClass IMay 30, 2024Failed Dissolution Specifications |
| Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-count bottle, Rx Only, Manufactured by: GlenmaClass IIMay 30, 2024CGMP Deviations |
| Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: GlenmaClass IMay 30, 2024Failed Dissolution Specifications |
| Rizatriptan Benzoate Orally Disintegrating Tablets, USP 10mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark PClass IIMay 13, 2024CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity re |
| Rizatriptan Benzoate Orally Disintegrating Tablets, USP 5mg, 18 (3 x 6) Unit-Dose Tablets, Manufactured for: Glenmark PhClass IIMay 13, 2024CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity re |
| Rizatriptan Benzoate Tablets USP, 10 mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., Class IIMay 10, 2024CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity re |
| Rizatriptan Benzoate Tablets USP, 5mg, 18 (3 X 6) Unit-Dose Tablets, Manufactured for: Glenmark Pharmaceuticals Inc., USClass IIMay 10, 2024CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity re |
| Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, ManClass IIApr 17, 2024Failed Dissolution Specifications |
| Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, ManClass IIMar 26, 2024Failed Dissolution Specifications: Out of Specification (OOS |
| Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: GlClass IIJan 4, 2024Failed Excipient Specifications: OOS for assay of Isopropyl |
| Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, GClass IINov 7, 2023Labeling: Label Mix-Up-Indomethacin bottles may be labeled a |
| Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-BardeClass IINov 7, 2023Labeling: Label Mix-Up-Indomethacin bottles may be labeled a |
| Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals LimClass IIOct 23, 2023Failed Dissolution Specifications: Out of specification for |
| Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-cClass IIIOct 23, 2023Failed Impurities/Degradation Specifications:Out of Specific |
| Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 5mg/6.25mg, 100-count Bottle, RX only, Manufactured by: GlenmaClass IIIOct 20, 2023Failed Impurities/Degradation Specifications |
| Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals IncClass IIOct 20, 2023Failed Dissolution Specifications |
| Trandolapril and Verapamil Hydrochloride Extended-Release Tablets 2 mg / 180 mg, 100-count Bottle, Rx only, ManufacturedClass IIIAug 14, 2023Subpotent: Out of Specification for Assay Test at the 3-mont |
| Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35,Class IIIJul 11, 2022Defective Container: Tube split from side seam |
| Desmopressin Acetate Tablets, 0.2 mg, 100-count bottles, Rx Only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141,Class IIJun 29, 2022CGMP Deviations |
| Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark PharmaceuClass IIJun 29, 2022Defective Container: Recall of these batches has been initia |
| Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark PharmaceutiClass IIJun 29, 2022Defective Container: Recall of these batches has been initia |
| Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bottle, Rx Only, Manufactured for: Glenmark PhClass IIIJun 29, 2022Failed Tablet/Capsule Specification : Capsule breakage |
| Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC 68462-385-37), b) 60 ml-bottle (NDC 68462-3Class IIIJun 16, 2022Defective Container |
| Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc.,Class IIApr 25, 2022cGMP deviations |
| Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-13Class IIApr 25, 2022cGMP deviations |
| Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc.Class IIApr 25, 2022cGMP deviations |
| Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark PharmaClass IIAug 27, 2021Lack of Assurance of Sterility |
| Fulvestrant Injection 250 mg/5 mL (50 mg/mL) For Intramuscular Use Only Contains 2 single-dose pre-filled syringes Rx onClass IIAug 27, 2021Lack of Assurance of Sterility |
| Zonisamide Capsules USP 100 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 ManufacturedClass IIAug 27, 2021CGMP Deviations |
| Chlorzoxazone Tablets USP 375 mg 100 Tablets Rx Only NDC 68462-724-01 Manufactured by: Glenmark Pharmaceuticals Inc., UClass IIAug 27, 2021CGMP Deviations |
| Naproxen Sodium Tablets, USP 275 mg 100 Tablets Rx Only NDC 68462-178-01 Manufactured by: Glenmark Pharmaceuticals Inc.,Class IIAug 27, 2021CGMP Deviations |
| Naproxen Sodium Tablets, USP 550 mg Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA 4147 Goldmine Road MonroClass IIAug 27, 2021CGMP Deviations |
| Zonisamide Capsules USP 50 mg 100 Capsules Rx Only NDC 68462-129-01 Manufactured by: Glenmark Pharmaceuticals Inc., USA Class IIAug 27, 2021CGMP Deviations |
| Chlorzoxazone Tablets USP 750 mg 100 Tablets Rx Only NDC 68462-725-01 Manufactured by: Glenmark Pharmaceuticals Inc., UClass IIAug 27, 2021CGMP Deviations |