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 #: 29906202Exp 12/1829993102Exp 2/193036610230373103Exp 4/1931940601Exp 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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