Drug recall D-0653-2016
Product
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.
Lots and codes
Lot #: BPA512A; Expiry: 06/2017.
Recall details
- Recalling firm
- Macleods Pharma Usa Inc, Plainsboro, NJ
- Quantity
- N/A
- Distribution
- US Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 24, 2015
- Terminated
- August 31, 2020
Related products
- pramipexole dihydrochloride – drug information
- NDC 33342-032 Pramipexole dihydrochloride · Pramipexole Dihydrochloride .25 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-031 Pramipexole dihydrochloride · Pramipexole Dihydrochloride .125 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-034 Pramipexole dihydrochloride · Pramipexole Dihydrochloride 1 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-033 Pramipexole dihydrochloride · Pramipexole Dihydrochloride .5 mg/1 · Macleods Pharmaceuticals Limited
- NDC 33342-035 Pramipexole dihydrochloride · Pramipexole Dihydrochloride 1.5 mg/1 · Macleods Pharmaceuticals Limited