D-0378-2015 Class II Terminated
FDA drug recall D-0378-2015 was initiated by Mylan Institutional, Inc. (D.B.A. UDL Laboratories) on Sep 26, 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 Nov 9, 2015). Affected quantity: 3,993 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 28, 2015
- Initiation Date
- Sep 26, 2013
- Termination Date
- Nov 9, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,993 cartons
Product Description
LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20
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 Number: 3038124; Expiration Date: 1/14; NDC: 51079-866-20;
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0378-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026