Mylan Institutional, Inc. (d.b.a. UDL Laboratories): CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Agency Publication Date: August 23, 2016

Affected Products

Product: 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.

Lot #: a) 3039792, Exp 04/14; 3037880, Exp 01/14; 3043938, Exp 07/14; b) 3036811, Exp 10/13; 3037514, Exp 01/14; 3039975, Exp 04/14; 3042583, Exp 07/14

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.

Lot #: a) 3038339, Exp 02/14; 3043618, Exp 06/14; b) 3041862, Exp 05/14; 3044258, Exp 06/14; c) 2120031, Exp 01/14; 2120067, Exp 06/14; d) 3035787, 3035834, 3035835, Exp 10/13; 3037125, 3037126, 3037127, 3037511, 3037512, 3037513, Exp 01/14; 3038113, 3038114, 3038115, 3038116, 3039641, 3039642, 3039643, 3039974, Exp 02/14; 3040567, 3040977, Exp 04/14; 3041253, 3041800, 3041801, Exp 05/14; 3042446, 3042624, 3043015, Exp 06/14; 3043401, 3043466, Exp 08/14; 3044590, Exp 09/14; 3044591, Exp 10/14; 3045063, 3045064, Exp 11/14

Product: Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed By: UDL Laboratories, Inc., Rockford, IL 61103.

Lot #: a) 3039795, 3042896, Exp 04/14; b) 3039793, 3042892, Exp 04/14; c) 2120054, Exp 02/14; 2120090, Exp 05/14

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66393

Status: Resolved

Manufacturer: Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Manufactured In: United States

Units Affected: 3 products (a) 9,156 cartons; b) 521,310 cartons; a) 42,733 cartons; b) 3,267 cartons; c) 10,303 cartons; d) 4,262,856 cartons; a) 11,064 cartons; b) 2,052 cartons; c) 5,567 cartons)

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Sources: FDA iRES · Raw API Response

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