PlainRecalls
FDA Drug Moderate Class II Terminated

Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.

Reported: February 17, 2016 Initiated: December 24, 2015 #D-0653-2016

Product Description

Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.

Reason for Recall

Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.

Details

Recalling Firm
Macleods Pharma Usa Inc
Units Affected
N/A
Distribution
US Nationwide.
Location
Plainsboro, NJ

Frequently Asked Questions

What product was recalled?
Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.. Recalled by Macleods Pharma Usa Inc. Units affected: N/A.
Why was this product recalled?
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Which agency issued this recall?
This recall was issued by the FDA Drug on February 17, 2016. Severity: Moderate. Recall number: D-0653-2016.