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D-0045-2025Class III

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Recalling firm
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Product type
Drug
Status
Terminated
Report date
2024-11-20
Distribution
Nationwide in the US.
Firm state
TN
Product quantity
25814 tablets
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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.

Code / lot info

Lot#: T04888, Exp 11/2024; T04946, Exp 12/2024; T04970, Exp 07/2025

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.