D-1466-2016 Class II Terminated
FDA drug recall D-1466-2016 was initiated by Mylan Institutional, Inc. (D.B.A. UDL Laboratories) on Sep 17, 2013 and is designated Class II. Reason for recall: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. The recall status is terminated (terminated Apr 24, 2018). Affected quantity: a) 9,156 cartons; b) 521,310 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 31, 2016
- Initiation Date
- Sep 17, 2013
- Termination Date
- Apr 24, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- a) 9,156 cartons; b) 521,310 cartons
Product Description
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.
Reason for Recall
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Distribution Pattern
Nationwide, Puerto Rico and Guam
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1466-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026