Drug 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
D-1851-2019
Product summary
- Event
- Event 83597
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1837 90-count bottles
- Official record key
drug-enforcement:D-1851-2019
Official wording
Reason: Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Code information: Lot #BPA801A, EXP 12/2020
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Subpotent