FDAFDA · Food and drugs·Recall number D-1431-2019
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
Published July 3, 2019 · Recall initiated: May 13, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- American Health Packaging
- Distributor
- Nationwide USA
- Lot
- Lot, expiry: Lot 179049, exp 12/31/2019; Lot 182571, exp 8/31/2020
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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