Recalls / Class II
Class IID-0378-2015
Product
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
- Affected lot / code info
- Lot Number: 3038124; Expiration Date: 1/14; NDC: 51079-866-20;
Why it was recalled
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
Recalling firm
- Firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1718 Northrock Ct, N/A, Rockford, Illinois 61103-1201
Distribution
- Quantity
- 3,993 cartons
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2013-09-26
- FDA classified
- 2015-01-21
- Posted by FDA
- 2015-01-28
- Terminated
- 2015-11-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0378-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.