D-66403-001 Class II Terminated
FDA drug recall D-66403-001 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: 37,752 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
- 37,752 bottles
Product description
Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), 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) 3037907, 3040106; b) 3037907, 3040106, 3044357
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-66403-001
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026