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Antacid Solution, Tablets Recalled


March 20, 2020

Precision Dose Inc. and American Health Packaging are recalling ranitidine products because of potential contamination with the probable human carcinogen N-Nitrosodimethylamine (NDMA), according to the March 18, 2020, US Food and Drug Administration (FDA) Enforcement Report. 

Precision Dose is recalling ranitidine oral solution, 150 mg/10 mL (unit-dose cup NDC 68094-204-59; 30-cup case NDC 68094-204-62; 100-cup case NDC 68094-204-61) distributed throughout the United States from lots 501290 (Exp. 11/30/19), 501326 (Exp. 11/30/19), 501501 (Exp. 11/30/19), 501592 (Exp. 4/30/20), and 501679 (Exp. 4/30/20).  

American Health Packaging is recalling ranitidine tablets, 150 mg, 100 tablets (10 blister cards containing 10 tablets each; card NDC 60687-322-11, carton NDC 60687-322-01), distributed throughout the United States from lots 179516 and 179745 (Exp. 12/31/19); 180712 (Exp. 2/29/20); 180819 (Exp. 4/30/20); 181403, 182544, 183155, and 183236 (Exp. 5/31/20); and 185739, 186600, and 186702 (Exp. 12/31/20). 

The voluntary recalls were initiated by Precision Dose on November 13, 2019, and by American Health Packaging on November 20, 2019. The FDA designated the recalls Class II on March 12, 2020. Drugs affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists. 

Prescription ranitidine is used to treat ulcers, gastroesophageal reflux disease, and other conditions that cause excess stomach acid.

Jolynn Tumolo

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