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.
Reported: August 31, 2016 Initiated: September 17, 2013 #D-1468-2016
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.
Details
- Recalling Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Units Affected
- a) 11,064 cartons; b) 2,052 cartons; c) 5,567 cartons
- Distribution
- Nationwide, Puerto Rico and Guam
- Location
- Rockford, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Mylan Institutional, Inc. (d.b.a. UDL Laboratories). Units affected: a) 11,064 cartons; b) 2,052 cartons; c) 5,567 cartons.
Why was this product recalled? ▼
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 31, 2016. Severity: Moderate. Recall number: D-1468-2016.
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