Mylan Pharmaceuticals Inc. recalls Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-

Recalled November 13, 2013 · FDA recall D-66403-003 · Mylan Pharmaceuticals

Hazard

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. · FDA Class II

Units

28,140 bottles

Sold at

Nationwide and Puerto Rico

Description

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Product

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.

Manufacturer(s)

Mylan Pharmaceuticals Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →