Class III · Low risk
Pramipexole Dihydrochloride Tablets 0.125 mg
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Pramipexole Dihydrochloride Extended Release Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Pramipexole Dihydrochloride Extended Release Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11
Affected NDC
10370-0251-11
Compare with the code on your package — it is the most precise check available.
Drug: Pramipexole
- Recalling firm
- Par Pharmaceutical
- NDC code
- 10370-251-11
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1038-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Pramipexole recalls
See all
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Other recalls by Par Pharmaceutical
All 2016 recalls
Class II · Moderate risk
BusPIRone Hydrochloride Tablets
Failed Impurity /Degradation Specifications
Class II · Moderate risk
Glycopyrrolate Tablets
Failed Impurities/Degradation Specification: Presence of unknown impurity observed.
Class III · Low risk
PrediniSONE Tablets
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
Class III · Low risk
Frovatriptan Succinate Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
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