D-66403-003 Class II Terminated
FDA drug recall D-66403-003 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: 28,140 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
- 28,140 bottles
Product description
Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), 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) 2003194, 2003195; b) 2003193
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-66403-003
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026