Recall: D-1851-2019

Class III - Minor Violations

Class IIIClassification

2019-08-21Initiated

TerminatedStatus

Macleods Pharma Usa IncFirm

Product

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

Reason

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

Distribution

Distributed Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.