The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

FDA Drug Class II Ongoing

Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7133-61,

September 12, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 1394 blister packs units

FDA Drug Class II Ongoing

Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7132-61,

September 12, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 866 blister packs units

FDA Drug Class II Ongoing

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-06, UP

September 12, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 2064 blister packs units

FDA Drug Class II Ongoing

Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7130-61,

September 12, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 1256 blister packs units

FDA Drug Class II Ongoing

Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-7131-61,

September 12, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 506 blister packs units

FDA Drug Class II Ongoing

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, Indianapol

September 2, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories N/A units

FDA Drug Class II Ongoing

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 (O

September 2, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories N/A units

FDA Drug Class II Ongoing

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

August 20, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 26,628 cartons units

FDA Drug Class II Ongoing

ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61

April 14, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 133 cartons units

FDA Drug Class III Terminated

Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6592-04.

March 4, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 224 cartons units

FDA Drug Class II Ongoing

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 Ro

January 30, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 6997 cartons units

FDA Drug Class II Ongoing

Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-905 Leading Pharma, LLC., Packaged and D

January 21, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 94,349 cartons units

FDA Drug Class II Ongoing

Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-904 Leading Pharma, LLC., Packaged and

January 21, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 82,281 cartons units

FDA Drug Class II Ongoing

Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package is from NDC # 69315-906 Leading Pharma, LLC., Packaged and D

January 21, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 27,525 cartons units

FDA Drug Class II Completed

Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (10x10 blister packs) NDC 0904-7043-61, Rx only, Packaged and D

January 13, 2025 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories a) 6408 boxes and b)1488 boxes units

FDA Drug Class II Completed

Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70

November 7, 2024 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories N/A units

FDA Drug Class II Completed

Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72

November 7, 2024 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories N/A units

FDA Drug Class III Terminated

Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, Distributed by: MAJOR Pharmaceuticals, Livonia, MI, 48152, USA

November 5, 2024 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 25814 tablets units

FDA Drug Class II Terminated

Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Major Pharmaceutical 1

June 18, 2024 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 864 cartons units

FDA Drug Class II Terminated

HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharm

February 9, 2024 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 8,198 units units

FDA Drug Class I Terminated

Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.

October 31, 2023 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 1,271,810 bottles units

FDA Drug Class I Terminated

Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94

October 31, 2023 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 65,880 bottles units

FDA Drug Class I Terminated

Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152

October 23, 2023 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories 3718 saleable units units

FDA Drug Class I Terminated

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 4

May 31, 2023 The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories unknown units