Tablet Mix-Up Prompts Recall

Unichem Pharmaceuticals USA Inc is recalling 18,960 bottles of 0.3-mg clonidine hydrochloride tablets because they mistakenly contain 0.2-mg tablets, according to the September 28, 2022, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 100-count bottles (NDC 29300-137-01) manufactured by Unichem Laboratories Ltd, Bardez, Goa, India, for Unichem Pharmaceuticals USA, East Brunswick, NJ, from lot GCLH22005 (Exp. 2/29/24). The bottles were distributed throughout the United States.

Unichem Pharmaceuticals USA initiated the recall September 19, 2022. On September 22, 2022, the FDA designated the recall Class III. Under the recall classification, use of the affected tablets is not likely to cause harm.

Clonidine hydrochloride is a prescription medication indicated for the treatment of hypertension.