FDA-Drug2022-03-23Class II
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
The Harvard Drug Group
Hazard
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Sold states
Nationwide within USA
Affected count
5,953 cartons
Manufactured in
17187 N Laurel Park Dr Ste 300, N/A, Livonia, MI, United States
Products
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0653-2022Don't want to check this manually?
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