D-66403-009 Class II Terminated
FDA drug recall D-66403-009 was initiated by Mylan Pharmaceuticals Inc. on Sep 13, 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 Jul 23, 2015). Affected quantity: 42,174 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 13, 2013
- Initiation Date
- Sep 13, 2013
- Termination Date
- Jul 23, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42,174 bottles
Product description
Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part ***Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.***
Reason for recall
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Distribution pattern
Nationwide and Puerto Rico
Code information
Lot #: a) 2003177, 2003178, 2003179, 2003180, 3043496; b) 2003176, 2003177, 3043496
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-66403-009
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026