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Hypertension Drug Recalled
Golden State Medical Supply Inc is recalling numerous lots of enalapril maleate tablets due to deviations from Current Good Manufacturing Practice regulations, according to the July 13, 2022, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects the following products, manufactured by Taro Pharmaceutical Industries Ltd, packaged by Golden State Medical Supply, and distributed in Pennsylvania, Massachusetts, Ohio, Texas, Illinois, North Dakota, and Hawaii:
- enalapril maleate tablets, 2.5 mg, 90-count bottles (NDC 60429-183-90), from lots GS028301 (Exp. 6/22), GS029973, GS029974, GS031436, GS031715, GS033191, and GS033940 (Exp. 10/22), GS034212 (Exp. 12/22), GS035315, GS035945, GS036905, GS038038, and GS039199 (Exp. 4/23), and GS039200 and GS040149 (Exp. 11/23);
- enalapril maleate tablets, 5 mg, 90-count bottles (NDC 60429-184-90), from lots GS029041, GS029353, and GS02986 (Exp. 9/22), GS030056, GS030869, and GS033943 (Exp. 10/22), GS034490 and GS035197 (Exp. 2/23), GS035198 (Exp. 3/23), GS035596, GS035947, GS036759, and GS037400 (Exp. 6/23), GS038089, GS038763, GS039559, and GS040150 (Exp. 10/23), GS040151, GS040708, and GS041107 (Exp. 12/23), and GS041654 (Exp. 3/24);
- enalapril maleate tablets, 10 mg, 90-count bottles (NDC 60429-185-90), from lots GS027890, GS028177, and GS028488 (Exp. 4/22), GS028847 and GS028848 (Exp. 9/22), GS029627, GS029862, GS030057, GS030481, GS030870, GS031060, GS031437, GS031438, GS033527, and GS034231 (Exp. 10/22), GS034810 (Exp. 1/23), GS035240 and GS035598 (Exp. 5/23), GS036194 (Exp. 6/23), GS036760, GS036981, GS037526, GS038177, and GS038728 (Exp. 8/23), GS038729 and GS041108 (Exp. 9/23), GS039412, GS039840, and GS041109 (Exp. 12/23), GS041655 (Exp. 1/24), and GS041656 (Exp. 5/24); and
- enalapril maleate tablets, 20 mg, 90-count bottles (NDC 60429-186-90), from lots GS035031 and GS035199 (Exp. 3/22), GS036495 and GS036904 (Exp. 5/22), GS037401 (Exp. 9/22), GS037986, GS038359, and GS039560 (Exp. 11/22), and GS041110 (Exp. 12/22).
Golden State Medical Supply voluntarily initiated the recall March 16, 2022. On July 7, 2022, the FDA designated the recall Class II, signaling use of the tablets could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Enalapril maleate is a prescription medication indicated for the treatment of hypertension, heart failure, and asymptomatic left ventricular dysfunction.
