Lacosamide oral solution recalled for failed excipient specifications
Camber Pharmaceuticals is recalling specific lots of Lacosamide oral solution due to out-of-specification p-Hydroxybenzoic Acid content. The recall affects multiple lot numbers distributed nationwide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: This is an FDA Class III recall, the lowest classification level, with no reported illnesses or injuries. The issue represents a manufacturing specification failure without confirmed safety harm, consistent with precautionary quality-control recalls.
Plain-English summary
Camber Pharmaceuticals, Inc. is recalling Lacosamide Oral Solution, USP, 10mg/mL, distributed in 200 mL bottles due to failed excipient specifications.
The recall was initiated after laboratory testing identified out-of-specification results for p-Hydroxybenzoic Acid content in the affected lot numbers: E222200 and E222199 (expiring 05/2024) and E222228 (expiring 06/2024).
The product was distributed nationwide. No illnesses or injuries have been reported. Consumers with affected lots should consult their healthcare provider or pharmacist before using the product.
The recalled product
- Product
- LACOSAMIDE (LACOSAMIDE)
- Brand
- LACOSAMIDE
- Manufacturer
- Camber Pharmaceuticals, Inc
- Category
- Drug — Oral Solution
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 (5)
- Lot#: E222200
- E222199
- Exp 05/2024
- E222228
- Exp 06/2024
UPCs (2)
- 0331722627467
- 0331722627269
Distribution
Distributed nationwide across the United States.
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