Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451
Recalled August 31, 2016 · FDA recall D-1467-2016 · 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. · FDA Class II
Units
a) 42,733 cartons; b) 3,267 cartons; c) 10,303 cartons; d) 4,262,856 cartons
Sold at
Nationwide, Puerto Rico and Guam
Description
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Product
Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d) 30-count tablets per dosage card in a carton, NDC 51079-451-69, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.
Manufacturer(s)
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →