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
Mirapex (pramipexole dihydrochloride)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Mirapex (pramipexole dihydrochloride) Tablets, 1 mg, 100-count unit-dose tablets per folding carton, Rx only, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Made in Germany, NDC 0597-0190-61.
Affected NDC
0597-0190-61
Compare with the code on your package — it is the most precise check available.
Drug: Pramipexole
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- NDC code
- 0597-0190-61
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0991-2019 · 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 Boehringer Ingelheim Pharmaceuticals, Inc.
All 2019 recalls
Class II · Moderate risk
Synjardy XR Tablets
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Class II · Moderate risk
JARDIANCE (Empagliflozin)
Labeling: Label Mix-up
Class II · Moderate risk
Micardis Tablets
Subpotent Drug
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
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