D-66403-012 Class II Terminated
FDA drug recall D-66403-012 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: 101,450 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
- 101,450 bottles
Product description
Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, 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) 3038984, 3038985, 3038986, 3041484, 3041485; b) 3036828, 3036829, 3036830, 3036831, 3036832, 3038987, 3038988, 3038989, 3038990, 3041480, 3041481, 3041482, 3041483, 3044522, 3044525
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-66403-012
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026