FDA-Drug2024-11-20Class III
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.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Hazard
Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Sold states
Nationwide in the US.
Affected count
25814 tablets
Manufactured in
341 Mason Rd, N/A, La Vergne, TN, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0045-2025Don't want to check this manually?
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