Drug Recall: 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 Pharm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · February 9, 2024
Reason for Recall
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.
Product Description
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
Distribution
The product was distributed nationwide within the United States.
States Affected
NATIONWIDE
Quantity Affected
8,198 units
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0324-2024
Status: terminated
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