Reported Sep 18, 2019 · Terminated
Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc.…
Macleods Pharma USA Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Macleods Pharma Usa Inc · 666 Plainsboro Rd Bldg 200 Ste 230 · Plainsboro, NJ · 08536-0009
Is this the product you have?
Pramipexole Dihydrochloride Tablets 0.125 mg90-count bottleRx Only
- Manufactured forMacleods Pharma USA, Inc. Plainsboro, NJ 08536
- Manufactured byMacleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 33342-031-10
- Lot codes and dates
Lot #BPA801AEXP 12/2020
- Amount recalled
- 1837 90-count bottles
Where it was sold
- Nationwide
Why it was recalled
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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