Drug recall D-1851-2019
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 for recall
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Lots and codes
Lot #BPA801A, EXP 12/2020
Recall details
- Recalling firm
- Macleods Pharma Usa Inc, Plainsboro, NJ
- Quantity
- 1837 90-count bottles
- Distribution
- Distributed Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 21, 2019
- Terminated
- January 28, 2021
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