Akorn Lidocaine Oral Solution Recalled Due to Manufacturing Compliance Deviations
Akorn Operating Company is recalling all lots of Lidocaine Hydrochloride Oral Topical Solution 2% distributed nationally because the firm ceased operations and could not complete required stability studies.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is regulatory and administrative in nature—the firm's inability to complete stability studies—rather than an identified safety defect with reported harm. This qualifies as a precautionary recall.
Plain-English summary
Akorn Operating Company LLC is recalling all lots of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes distributed nationwide in the USA and Puerto Rico. The prescription medication is being recalled due to Good Manufacturing Practice (GMP) compliance deviations.
The firm went out of business and was unable to continue stability studies required to ensure the product maintains its safety and effectiveness during its shelf life. Stability studies are a critical part of demonstrating that a pharmaceutical product remains safe and effective until its expiration date.
This recall affects all lots of this product. Patients currently using this medication should consult with their healthcare provider or pharmacist about alternative treatments. Healthcare facilities and pharmacies should remove this product from their shelves.
The recalled product
- Product
- Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100mL tubes, Rx Only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. ALL NDCs
- Manufacturer
- Akorn, Inc.
- Category
- Drug
- Hazard
- manufacturing-deviation
- stability-unverified
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)
- All Lots
Distribution
Distributed nationwide across the United States.
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