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Blood Pressure Drug Recalled
Unichem Pharmaceuticals (USA) Inc. is recalling four lots of clonidine hydrochloride tablets, 0.1 mg, for failing to meet impurity specifications. The June 17, 2020, US Food and Drug Administration (FDA) Enforcement Report specifies the recall reason as “potential migration of benzophenone at very low level into the product from container.”
The recall affects clonidine hydrochloride tablets, 0.1 mg, in 100-count bottles (NDC 29300-135-01) from lots GCLL19034, GCLL19035, and GCLL19036 (Exp. 4/30/21), and GCLL19044 (Exp. 6/30/21). The bottles were distributed throughout the United States.
Unichem Pharmaceuticals initiated the voluntary recall May 26, 2020. The FDA designated the recall Class III on June 8, 2020. Under the recall classification, use of the affected tablets is not likely to cause harm.
Clonidine hydrochloride is a prescription drug used to treat hypertension.
—Jolynn Tumolo
