FDA Drug Class II — Moderate

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

Hazard

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

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Products

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
Brand
Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
UPC
Lot Number: 3038124; Expiration Date: 1/14; NDC: 51079-866-20;

Units Affected

3,993 cartons

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