FDA-Drug2019-07-03Class II
Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01
American Health Packaging
Hazard
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Sold states
Nationwide USA
Affected count
16,698 cartons
Manufactured in
2550 John Glenn Ave Ste A, N/A, Columbus, OH, United States
Products
Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 NDC Blister Card: 68084-440-11; NDC Carton: 68084-440-01
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1432-2019Don't want to check this manually?
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