Recalls / Class II
Class IID-1468-2016
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.
- Affected lot / code info
- Lot #: a) 3039795, 3042896, Exp 04/14; b) 3039793, 3042892, Exp 04/14; c) 2120054, Exp 02/14; 2120090, Exp 05/14
Why it was recalled
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, Rockford, Illinois 61103-1201
Distribution
- Quantity
- a) 11,064 cartons; b) 2,052 cartons; c) 5,567 cartons
- Distribution pattern
- Nationwide, Puerto Rico and Guam
Timeline
- Recall initiated
- 2013-09-17
- FDA classified
- 2016-08-23
- Posted by FDA
- 2016-08-31
- Terminated
- 2018-04-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1468-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.