CLASS II Drug recall · Reported 3 Jul 2019 · FDA Enforcement Report
Pramipexole Dihydrochloride Tablets, 0.125 mg per blister card) recalled
American Health Packaging is recalling Pramipexole Dihydrochloride Tablets, 0.125 mg per blister card), distributed nationwide in the US. The recall was initiated on 13 May 2019 and the FDA has classified it as Class II.
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-1431-2019
- FDA event ID
- 82863
- Recalling firm
- American Health Packaging, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 May 2019
- FDA classified
- 27 Jun 2019
- Reported
- 3 Jul 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Processing Deviation
Timeline
| 13 May 2019 | Recall initiated by company | |
| 27 Jun 2019 | Classified by FDA | +45 days |
| 3 Jul 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
The USDA issues these when meat or poultry was produced without proper inspection, or when a step such as cooking or pasteurisation did not meet requirements.
Product as listed by the FDA
Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-793-95; NDC Carton: 68084-793-25
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Which lots are affected?
Lot, expiry: Lot 179049, exp 12/31/2019; Lot 182571, exp 8/31/2020
Where was it sold?
Nationwide USA
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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
3 other products · FDA event 82863| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Pramipexole Dihydrochloride Tablets, 1.0 mg per blister card) recalled | American Health Packaging | Processing Deviation | Nationwide | |
| CLASS II | Pramipexole Dihydrochloride Tablets, 0.5 mg per blister card) recalled | American Health Packaging | Processing Deviation | Nationwide | |
| CLASS II | Pramipexole Dihydrochloride Tablets, 0.25 mg (10 recalled | American Health Packaging | Processing Deviation | Nationwide |
More recalls from American Health Packaging
All 60| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate | American Health Packaging | Potency & Assay | 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 1 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |