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the harvard drug group llc dba major pharmaceuticals and rugby laboratories

10 recalls on record

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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distri

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distri

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distri

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distrib

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distribut

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distri

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit

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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b)

CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit

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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapoli

Failed Impurity/Degradation Specifications

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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapol

Failed Impurity/Degradation Specifications

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The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories — Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Bruns

Failed Impurities/Degradation Specifications; during routine stability testing for impurities.