Recalls / Class II
Class IID-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.
- Brand name
- Pramipexole Dihydrochloride
- Generic name
- Pramipexole Dihydrochloride
- Active ingredient
- Pramipexole Dihydrochloride
- Route
- Oral
- NDCs
- 33342-031, 33342-032, 33342-033, 33342-034, 33342-035
- FDA application
- ANDA202164
- Affected lot / code info
- Lot #: BPA512A; Expiry: 06/2017.
Why it was recalled
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Recalling firm
- Firm
- Macleods Pharma Usa Inc
- Manufacturer
- Macleods Pharmaceuticals Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd, Bldg 200 Ste 230, Plainsboro, New Jersey 08536-3030
Distribution
- Quantity
- N/A
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2015-12-24
- FDA classified
- 2016-02-05
- Posted by FDA
- 2016-02-17
- Terminated
- 2020-08-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0653-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.