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Pain Reliever Recalled


March 20, 2020

HJ Harkins Company Inc., which does business as Pharma Pac, is recalling a single lot of 500-mg acetaminophen tablets after a customer reported finding a prenatal dietary supplement in a bottle, according to the March 18, 2020, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects acetaminophen 500-mg tablets in 30-count bottles (NDC 52959-0002-30), 42-count bottles (NDC 52959-0002-42), 45-count bottles (NDC 52959-0002-45), and 50-count bottles (NDC 52959-0002-50) from lot AE00M (Exp. 8/21). The bottles were distributed throughout the United States. 

HJ Harkins Company voluntarily initiated the recall March 6, 2020. On March 12, 2020, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists. 

Acetaminophen is an analgesic medication used to treat mild to moderate pain and to reduce fever. 

Jolynn Tumolo

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