Parkinson, Restless Leg Drug Pulled for Subpotency

Macleods Pharma USA Inc. is recalling a single lot of 90-count bottles of pramipexole dihydrochloride tablets, 0.125 mg (NDC 33342-031-10), after results from stability testing suggested the tablets may be subpotent. The recall was included in the September 18, 2019, US Food and Drug Administration (FDA) Enforcement Report. 

The recall spans 1837 bottles from lot BPA801A (Exp. 12/20), which were distributed throughout the United States. 

Macleods Pharma USA voluntarily initiated the recall August 21, 2019. On September 11, 2019, the FDA designated the recall Class III. Under the recall classification, use of the affected tablets is not likely to cause harm.

Pramipexole dihydrochloride is a prescription dopamine agonist used to treat Parkinson’s disease and restless legs syndrome. 

—Jolynn Tumolo