Drug 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.
D-0653-2016
Product summary
- Event
- Event 73017
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0653-2016
Official wording
Reason: Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Code information: Lot #: BPA512A; Expiry: 06/2017.
Distribution pattern: US Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
Foreign Tablets