D-1468-2016 Class II Terminated
FDA drug recall D-1468-2016 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) 11,064 cartons; b) 2,052 cartons; c) 5,567 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) 11,064 cartons; b) 2,052 cartons; c) 5,567 cartons
Product Description
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.
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) 3039795, 3042896, Exp 04/14; b) 3039793, 3042892, Exp 04/14; c) 2120054, Exp 02/14; 2120090, Exp 05/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1468-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026