CLASS III Drug recall · Reported 26 Sep 2012 · FDA Enforcement Report
Pramipexole Dihydrochloride Tablets recalled by Sandoz Incorporated
Sandoz is recalling Pramipexole Dihydrochloride Tablets, 0, distributed nationwide in the US. The recall was initiated on 12 Sep 2012 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1678-2012
- FDA event ID
- 63160
- Recalling firm
- Sandoz, Broomfield, CO
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Sep 2012
- FDA classified
- 19 Sep 2012
- Reported
- 26 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 12 Sep 2012 | Recall initiated by company | |
| 19 Sep 2012 | Classified by FDA | +7 days |
| 26 Sep 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Which lots are affected?
Lot numbers: KW10J511, KW10J512, KW10J513, KW10J514, KW10J515, BJ3167, BJ3172, BJ3177, BJ3179, BJ3188, BJ3182. Exp. 09/12
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 63160| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Pramipexole Dihydrochloride Tablets recalled by Sandoz Incorporated | Sandoz | Potency & Assay | Nationwide |
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|---|---|---|---|---|---|
| Drug | CLASS III | Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin | Sandoz | Other | Nationwide |
| Drug | CLASS II | Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide | Sandoz | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS I | Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium | Sandoz | Labeling Errors | Nationwide |
| Drug | CLASS I | Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin | Sandoz | Packaging Defects | Nationwide |
Other Pramipexole Dihydrochloride recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pramipexole Dihydrochloride Tablets 0.125 mg recalledPramipexole Dihydrochloride | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0.25 mg (10 recalled | American Health Packaging | Processing Deviation | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0.5 mg per blister card) recalled | American Health Packaging | Processing Deviation | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 1.0 mg per blister card) recalled | American Health Packaging | Processing Deviation | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0.125 mg per blister card) recalled | American Health Packaging | Processing Deviation | Nationwide |