American Health Packaging recalls Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American…
- Recall date
- May 13, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1434-2019
- FDA classification
- Class II
- Brand / firm
- American Health Packaging
- Sold / distributed
- Nationwide USA
Why it was recalled
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per blister card), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-982-95; NDC Carton: 68084-982-25
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