Recalls / Class III
Class IIID-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
- 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 #BPA801A, EXP 12/2020
Why it was recalled
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
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 08536-0009
Distribution
- Quantity
- 1837 90-count bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2019-08-21
- FDA classified
- 2019-09-11
- Posted by FDA
- 2019-09-18
- Terminated
- 2021-01-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1851-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.