Macleods Pharma Usa Inc recalls Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plai…

Recall date

August 21, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1851-2019

FDA classification

Class III

Brand / firm

Macleods Pharma Usa Inc

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10