FDA-Drug2019-06-26Class II
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16
Zydus Pharmaceuticals USA Inc
Hazard
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Sold states
Nationwide in the USA
Affected count
47,664 90-count bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1452-2019Don't want to check this manually?
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