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.
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: 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
- Hazard
- excipient-specification-failure
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)
- 0331722627269
- 0331722627467
Distribution
Distributed nationwide across the United States.
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