FDA-Drug2019-09-18Class III
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
Macleods Pharma Usa Inc
Hazard
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Sold states
Distributed Nationwide in the USA
Affected count
1837 90-count bottles
Manufactured in
666 Plainsboro Rd Bldg 200 Ste 230, Plainsboro, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1851-2019Don't want to check this manually?
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