Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Consumers and healthcare providers should stop using this product immediately. Contact The Harvard Drug Group LLC or your healthcare provider for guidance. Notification method: Letter
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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. Generic: OMEGA-3-ACID ETHYL ESTERS CAPSULES; Brand: OMEGA-3-ACID ETHYL ESTERS. Reason: Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.. Classification: Class II. Quantity: 2,238 5 x 10 unit dose cartons. Distribution: Nationwide in the USA
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Failed Dissolution Specifications
Major Pharmaceuticals recalled Gabapentin Capsules, USP, 100 mg, 10 capsules per blister pack, distributed nationwide in the United States. The recall cites failed impurities and degradation specifications from routine stability testing, specifically an out-of-spec Highest Unknown Impurity. Consumers and healthcare providers should stop using this product immediately and contact The Harvard Drug集团
Major Pharmaceuticals recalled Gabapentin capsules, 100 mg, 100-count, distributed nationwide in the United States. The recall stems from an out-of-spec highest unknown impurity found during stability testing. Healthcare providers and patients should stop using the product and contact The Harvard Drug Group LLC for guidance.
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Major Pharmaceuticals recalled 866 Chlorpromazine Hydrochloride 100 mg tablets distributed nationwide after CGMP deviations allowed N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. The impurity detected raises safety concerns for ongoing use. Stop using the product immediately and contact Harvard Drug Group LLC dba Major Pharmaceuticals or Rugby Laboratories for guidance and,
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