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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories FDA Recalls
24 recalls on file across drugs, 4 of them Class I and 13 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 |
|---|
| Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and DistClass IISep 12, 2025CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromaz |
| Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and DistClass IISep 12, 2025CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromaz |
| Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and DistrClass IISep 12, 2025CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromaz |
| Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and DistribClass IISep 12, 2025CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromaz |
| Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and DistClass IISep 12, 2025CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromaz |
| Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bagClass IISep 2, 2025Presence of a Foreign Substance: A specific lot of auxiliary |
| Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) perClass IISep 2, 2025Presence of a Foreign Substance: A specific lot of auxiliary |
| Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major PharmaceuticaClass IIAug 20, 2025CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 |
| ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and DistClass IIApr 14, 2025CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromaz |
| Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and DistrClass IIIMar 4, 2025Failed Dissolution Specifications: Out of specification resu |
| Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Class IIJan 30, 2025Failed Dissolution Specifications. |
| Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contClass IIJan 21, 2025Failed impurities/degradation specifications and Sub-potent |
| Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contaiClass IIJan 21, 2025Failed impurities/degradation specifications and Sub-potent |
| Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contaiClass IIJan 21, 2025Failed impurities/degradation specifications and Sub-potent |
| Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and bClass IIJan 13, 2025CGMP Deviations: presence of Nitrosamine Drug Substances Rel |
| Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, IndianapoClass IINov 7, 2024Failed Impurity/Degradation Specifications |
| Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, IndianapClass IINov 7, 2024Failed Impurity/Degradation Specifications |
| Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East BruClass IIINov 5, 2024Failed Impurities/Degradation Specifications; during routine |
| Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Class IIJun 18, 2024Failed dissolution specifications: out of specification resu |
| HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, ManufactuClass IIFeb 9, 2024an out of specification result obtained during routine stabi |
| Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGClass IOct 31, 2023Non-Sterility: FDA found insanitary conditions and positive |
| Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, LivoniClass IOct 31, 2023Non-Sterility: FDA found insanitary conditions and positive |
| Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per caseClass IOct 23, 2023Failed Content Uniformity Specifications |
| ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories LimitClass IMay 31, 2023Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasi |