Class III · Low risk Terminated
Pramipexole Dihydrochloride Tablets 0.125 mg
Reason Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
PRAMIPEXOLE DI-HCL Tablet
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.25 mg may be potentially mislabeled as TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: W003704, EXP: 6/26/2014.
What was recalled
PRAMIPEXOLE DI-HCL Tablet, 0.25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 16714058501
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-521-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Pramipexole recalls
See all
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk Terminated
Pramipexole Dihydrochloride Tablets
Reason GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
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