Reported Feb 17, 2016 · Terminated

Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc.,…

Macleods Pharma USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

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 · Plainsboro, NJ · 08536-3030

Is this the product you have?

    • Pramipexole Dihydrochloride Tablets 0.125 mg
    • 90 Ct Bottles
    • Rx Only
  • Manufactured forMacleods Pharma USA, Inc., Plainsboro, NJ 08536
  • Manufactured byMacleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA
  • NDC33342-031-10
Lot codes and dates
  • Lot #: BPA512A
  • Expiry06/2017
Amount recalled
N/A

Where it was sold

  • Nationwide

Why it was recalled

Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 31, 2020 · Data as of Sep 19, 7:00 PM UTC

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