The Recall Desk
ModerateFDA (Drugs)·D-0590-2021·Announced 2021-06-02

Cardinal Health Recalls VIMPAT Tablets Due to Temperature Excursions

Cardinal Health is recalling 882 bottles of VIMPAT (lacosamide) 200mg tablets due to intermittent temperature excursions during storage.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health Inc. is recalling 882 bottles of VIMPAT (lacosamide) 200mg tablets, 60-count bottles, due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated because the product experienced intermittent exposure to temperature excursions during storage.

The affected product is VIMPAT (lacosamide) Tablets, 200mg, 60-count bottle, Rx Only, manufactured for UCB, Inc. The specific NDC is 0131-2480-35, and the lot code is 912064. The recall is classified as Class II by the FDA.

The product was distributed in Florida, Georgia, and South Carolina. Consumers and healthcare providers should check their inventory for this specific lot and NDC. If found, the product should be returned to the pharmacy or point of distribution for a refund or replacement, as directed by the recalling firm.

The recalled product

Product
VIMPAT (LACOSAMIDE)
Brand
VIMPAT
Affected units
882

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 (1)

  • 912064

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health 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 198 products in this recall →