February 07, 2019
Mylan Pharmaceuticals Inc. is recalling 88,090 bottles of fexofenadine hydrochloride tablets, 180 mg, because samples failed to meet impurity/degradation specifications during routine stability testing, according to the February 6, 2019, US Food and Drug Administration (FDA) Enforcement Report.
The recall affects 30-count bottles (NDC 0378-0782-93) from lots 3085490 and 3085491 (Exp. 4/19) and 500-count bottles (NDC 0378-0782-05) from lots 3085492, 3085493, 3085494, 3085495, and 3085496 (Exp. 4/19). The bottles were distributed throughout the United States.
Mylan Pharmaceuticals voluntarily initiated the recall January 18, 2019. On February 4, 2019, the FDA designated the recall Class II, signaling use of the affected product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Fexofenadine is an antihistamine used to treat watery eyes, itching, sneezing, and other allergy symptoms.
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