Reported Sep 19, 2018 · Terminated

Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by:…

Par Pharmaceutical, 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: Par Pharmaceutical, Inc. · 1 Ram Ridge Rd · Chestnut Ridge, NY · 10977-6714

Is this the product you have?

  • Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only
  • Manufactured byPar Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11
Lot codes and dates
    • Lot #: 29906202
    • Exp 12/18
    • 29993102
    • Exp 2/19
    • 30366102
    • 30373103
    • Exp 4/19
    • 31940601
    • Exp 3/20
Amount recalled
16,207 (bottles of 30 tablets)

Where it was sold

  • Nationwide

Why it was recalled

Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

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

Read the FDA (openFDA drug enforcement) notice

Notice updated Dec 6, 2019 · Data as of Sep 19, 7:18 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.