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Recall Observatory FDA recall evidence

Drug 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.

D-1466-2016

September 17, 2013

Class II

Product summary

Firm
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Event
Event 66393
Status
Terminated
Classification
Class II
Quantity
a) 9,156 cartons; b) 521,310 cartons
Official record key
drug-enforcement:D-1466-2016

Official wording

Reason: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Code information: 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

Distribution pattern: Nationwide, Puerto Rico and Guam

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations