Wockhardt Recalls Lamotrigine Extended-Release Tablets Due to CGMP Deviations
Wockhardt USA LLC is recalling 5,910 bottles of Lamotrigine Extended-Release Tablets, 25 mg, because the firm did not adequately investigate customer complaints.
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 2/5 (Moderate).
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 due to CGMP deviations (inadequate complaint investigation) without reported illnesses or injuries, fitting the criteria for moderate severity involving procedural or low-risk issues.
Plain-English summary
Wockhardt USA LLC is recalling 5,910 bottles of Lamotrigine Extended-Release Tablets, 25 mg, 30 Count Bottles. The product is prescription-only and was distributed nationwide in the United States, including Puerto Rico. The specific lot number is DN10114, with an expiration date of 11/30/2015.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. The agency has classified this as a Class II recall.
Consumers with this product should contact their healthcare provider or pharmacist for guidance on how to dispose of or return the medication. Do not use the recalled product until further notice.
The recalled product
- Product
- Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-271-01.
- Manufacturer
- Wockhardt Usa Inc.
- Category
- Drug — Anticonvulsant
- Affected units
- 5,910
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 (2)
- Lot #: DN10114
- Expiry: 11/30/2015.
Distribution
Part of a larger recall action
This product is one of 35 recalled by Wockhardt Usa 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.
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