23 FDA recalls mention Pramipexole. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pramipexole.
Reason Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Reason Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Reason Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Reason Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it…
Reason Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Reason Labeling:Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg may be potentially mislabeled as LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC 42794001902…
Reason Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 1 mg may be potentially mislabel as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree…
Reason Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.25 mg may be potentially mislabeled as TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree…
Reason Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00904549213…
Reason Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Reason Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Reason Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
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