FDA-Drug2016-08-31Class II
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Hazard
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Sold states
Nationwide, Puerto Rico and Guam
Affected count
a) 9,156 cartons; b) 521,310 cartons
Manufactured in
1718 Northrock Ct, Rockford, IL, United States
Products
Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1466-2016Don't want to check this manually?
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