FDA-Drug2024-02-21Class II
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Hazard
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Sold states
The product was distributed nationwide within the United States.
Affected count
8,198 units
Manufactured in
341 Mason Rd, N/A, La Vergne, TN, United States
Products
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0324-2024Don't want to check this manually?
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