FDANovember 5, 2024drug

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, NDC 0904-6441-61.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

harvard drug group llc dba major pharmaceuticals and rugby laboratoriesharvardharvard drug

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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, NDC 0904-6441-61. — Recall Details · AllClear