The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls
FDA enforcement reports naming The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories as the recalling firm.
- Recall reports
- 24
- Class I (serious)
- 4
- Most recent report
- Oct 15, 2025
- Oct 15, 2025Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister pac…Drug · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesCGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limitClass II
- Oct 15, 2025Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister pa…Drug · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesCGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limitClass II
- Oct 15, 2025Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister pa…Drug · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesCGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limitClass II
- Oct 15, 2025Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister packa…Drug · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesCGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limitClass II
- Oct 15, 2025Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister pa…Drug · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesCGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limitClass II
- Sep 17, 2025Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets un…Drug · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesPresence 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 d…Class II
- Sep 17, 2025Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit…Drug · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesPresence 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 d…Class II
- Aug 27, 2025Carvedilol Tablets USP, 12Drug · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesCGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppmClass II
- Apr 23, 2025ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (1…Drug · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesCGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limitClass II
- Apr 9, 2025Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose ca…Drug · The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby LaboratoriesFailed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.Class III
- Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs),…
- Lorazepam Tablets, USP, 0
- Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs),…
- Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per cart…
- Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blis…
- Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Be…
- Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 B…
- Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Av…
- Venlafaxine Hydrochloride, extended-release capsules, USP, 37
- HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards)
- Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cup…
- Polyvinyl Alcohol 1
- Lubricating Tears Eye Drops (Dextran/Hypromellose), 0
- ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd
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