FDA-Drug2019-06-26Class II
Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10
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
204 1000-count bottles
Manufactured in
73 Route 31 N, N/A, Pennington, NJ, United States
Products
Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1442-2019Don't want to check this manually?
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