Major Pharamceuticals

2026

1. 13 de julio de 2026 · Clase II · En curso · D-0709-2026 · Levothyroxine

   Subpotent Drug

   Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He

2. 13 de julio de 2026 · Clase II · En curso · D-0707-2026 · Levothyroxine

   Subpotent Drug

   Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal He

3. 13 de julio de 2026 · Clase II · En curso · D-0711-2026 · Levothyroxine

   Subpotent Drug

   Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal

4. 13 de julio de 2026 · Clase II · En curso · D-0704-2026 · Levothyroxine

   Subpotent Drug

   Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 unit dose blisters) per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. NDC: 0904-6954-61

5. 13 de julio de 2026 · Clase II · En curso · D-0710-2026 · Levothyroxine

   Subpotent Drug

   Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) unit dose blisters per carton, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46268 USA. Distributed by Cardinal

6. 30 de junio de 2026 · Clase III · En curso · D-0735-2026 · Dabigatran etexilate

   Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

   Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68.

7. 30 de junio de 2026 · Clase III · En curso · D-0736-2026 · Dabigatran etexilate

   Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.

   Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10.

8. 16 de junio de 2026 · Clase II · En curso · D-0609-2026 · Methylergonovine maleate

   Subpotent Drug

   Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergonov

9. 9 de abril de 2026 · Clase II · En curso · D-0493-2026 · OMEGA-3-ACID ethyl esters

   Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.

   Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06

10. 24 de marzo de 2026 · Clase II · En curso · D-0485-2026 · Memantine hydrochloride

    Failed Dissolution Specifications

    Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61

11. 17 de febrero de 2026 · Clase II · En curso · D-0383-2026 · Midodrine hydrochloride

    Defective container; inadequately sealed blister packaging.

    Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.

2025

1. 10 de octubre de 2025 · Clase II · En curso · D-0031-2026 · Gabapentin

   Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

   Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag)

2. 10 de octubre de 2025 · Clase II · En curso · D-0030-2026 · Gabapentin

   Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .

   Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61

3. 2 de septiembre de 2025 · Clase II · En curso · D-0624-2025 · Sulfamethoxazole and trimethoprim

   Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

   Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC

4. 2 de septiembre de 2025 · Clase II · En curso · D-0625-2025 · Sulfamethoxazole and trimethoprim

   Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.

   Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-7895-0 (Outer Bag) containing

5. 20 de agosto de 2025 · Clase II · En curso · D-0594-2025 · Carvedilol

   CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm

   Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN, 46268, USA, NDC 0904-7307-61

6. 19 de junio de 2025 · Clase II · En curso · D-0507-2025 · Gabapentin

   Defective container; blister packaging inadequately sealed.

   Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61

7. 30 de enero de 2025 · Clase II · En curso · D-0221-2025 · Potassium chloride

   Failed Dissolution Specifications.

   Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distributed by: Aurobindo Pharma USA< INC., 279 Princeton-Hightstown Road, East Windsor, NJ

2023

1. 31 de mayo de 2023 · Clase I · Cerrado por la FDA · D-0893-2023 · Ziprasidone

   Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.

   ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6

2. 24 de abril de 2023 · Clase III · Cerrado por la FDA · D-0570-2023 · Gabapentin

   Product mixup: one foreign tablet found in product.

   Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 1717

2022

1. 13 de abril de 2022 · Clase II · Cerrado por la FDA · D-1059-2022 · Sulfamethoxazole and trimethoprim

   cGMP deviations: Temperature abuse

   Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-2725-61

2. 13 de abril de 2022 · Clase II · Cerrado por la FDA · D-1055-2022 · Ibuprofen

   cGMP deviations: Temperature abuse

   Ibuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61

3. 13 de abril de 2022 · Clase II · Cerrado por la FDA · D-1054-2022 · Doxycycline

   cGMP deviations: Temperature abuse

   Doxycycline Hyclate Tablets, USP, 100 mg, 50-count carton (10 tablets each blister pack x 5), Rx only, MFG: Major Pharma, NDC 0904-0430-06

4. 13 de abril de 2022 · Clase II · Cerrado por la FDA · D-1088-2022 · Levofloxacin

   cGMP deviations: Temperature abuse

   Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61

5. 28 de febrero de 2022 · Clase II · Cerrado por la FDA · D-0649-2022 · Paliperidone

   Failed Dissolution Specifications

   PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PH

2021

1. 6 de agosto de 2021 · Clase II · Cerrado por la FDA · D-0807-2021 · Carbamazepine

   Failed Dissolution Specifications

   Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distr

2. 29 de julio de 2021 · Clase II · Cerrado por la FDA · D-0806-2021 · Entacapone

   Failed Dissolution Specifications

   Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04

3. 2 de julio de 2021 · Clase II · Cerrado por la FDA · D-0652-2021 · Nifedipine

   Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.

   NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL

4. 15 de marzo de 2021 · Clase II · Cerrado por la FDA · D-0510-2021 · Trazodone hydrochloride

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   TRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETS

2020

1. 22 de mayo de 2020 · Clase II · Cerrado por la FDA · D-1288-2020 · Doxycycline

   Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.

   Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distribu

2. 27 de febrero de 2020 · Clase III · Cerrado por la FDA · D-1002-2020 · Quetiapine

   Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

   Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park

3. 27 de febrero de 2020 · Clase III · Cerrado por la FDA · D-1001-2020 · Quetiapine

   Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

   Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park

4. 27 de febrero de 2020 · Clase III · Cerrado por la FDA · D-0999-2020 · Quetiapine

   Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

   Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park D

5. 27 de febrero de 2020 · Clase III · Cerrado por la FDA · D-1000-2020 · Quetiapine

   Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

   Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park

2019

1. 24 de abril de 2019 · Clase II · Cerrado por la FDA · D-1583-2019 · Divalproex sodium

   cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.

   DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177

2018

1. 30 de julio de 2018 · Clase II · Cerrado por la FDA · D-1026-2018 · Doxycycline

   Failed Dissolution Specifications

   Doxycycline Hyclate Tablets, USP, 100 mg, Rx Only, 30 tablets, 3 x 10 unit dose Cartons, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NY 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Sui

2017

1. 5 de enero de 2017 · Clase II · Cerrado por la FDA · D-0689-2017 · Fluconazole

   Failed Dissolution Specifications

   Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI

2. 5 de enero de 2017 · Clase II · Cerrado por la FDA · D-0688-2017 · Fluconazole

   Failed Dissolution Specifications

   Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Distributed by MAJOR PHARMACEUTICALS, 31778 Enterprise Dr., Livonia, MI

Clase I: El tipo más grave: existe una probabilidad razonable de que usar el producto cause problemas de salud graves o la muerte.
Clase II: Usar el producto puede causar problemas de salud temporales o reversibles con tratamiento, o la probabilidad de problemas graves es remota.
Clase III: No es probable que usar el producto cause problemas de salud (por ejemplo, un problema de etiquetado o de envase).