FDAFDA · Food and drugs·Recall number D-1851-2019
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
Published September 18, 2019 · Recall initiated: August 21, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PRAMIPEXOLE DIHYDROCHLORIDE
- Manufacturer
- Macleods Pharma Usa Inc
- Distributor
- Distributed Nationwide in the USA
- UPC
- 0333342031105
- Lot
- Lot #BPA801A, EXP 12/2020
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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