LAMOTRIGINE TABLETS recalled over manufacturing violations

Recall date

September 26, 2013

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufact…

Recall number

D-0378-2015

FDA classification

Class II

Brand / firm

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Sold / distributed

Nationwide and Puerto Rico.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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