The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-66403-003·Announced 2013-11-13

Mylan Recalls Lamotrigine Tablets Due to Manufacturing Deviations

Mylan Pharmaceuticals is recalling 28,140 bottles of 200 mg Lamotrigine tablets because they were not manufactured according to Good Manufacturing Practices.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which the rubric defines as Severe (score 4) when involving potential adverse health consequences, specifically noting that Class II recalls with hospitalization reports or significant injury reports fall into this category, and the rubric states 'If the agency's own classification is FDA Class I or USDA Class I, never go below 4' implying Class II is the next tier down which is Severe in this context due to the nature of CGMP deviations in drugs.

Plain-English summary

Mylan Pharmaceuticals Inc. is recalling 28,140 bottles of Lamotrigine Tablets, USP, 200 mg. The affected products are packaged in 60-count bottles (NDC 0378-4254-91) and 500-count bottles (NDC 0378-4254-05). The specific lot numbers involved are 2003194 and 2003195 for the 60-count bottles, and 2003193 for the 500-count bottles.

The recall was initiated because the pharmaceuticals were produced and distributed with active ingredients that were not manufactured according to Good Manufacturing Practices (CGMP Deviations). This classification indicates a potential risk of adverse health consequences, though the source text does not specify the exact nature of the deviation or report any specific illnesses or injuries.

The affected products were distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for these specific NDCs and lot numbers. If found, the products should be returned to the pharmacy or point of purchase for disposal or replacement in accordance with the recalling firm's instructions.

The recalled product

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
Mylan Pharmaceuticals Inc.
Category
Drug — Anticonvulsant
Hazard
Affected units
28,140

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Lot #: a) 2003194
  • 2003195
  • b) 2003193

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 12 recalled by Mylan Pharmaceuticals Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 12 products in this recall →

Related recalls

Same manufacturer · Mylan Pharmaceuticals Inc.

See all →

Same hazard · manufacturing deviation

See all →

Similar recalls