Lidocaine Hydrochloride Topical Solution Recalled for Superpotency
Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution USP 4% due to manufacturing deviations. The recalled lot was produced at a facility where cracked seals in caps led to superpotent products.
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 II recall involving a manufacturing deviation (CGMP violation) with potential for superpotency. No illnesses or injuries are reported in the source text, and the recall is precautionary in nature to address the facility defect and cracked seals that created the risk.
Plain-English summary
Teligent Pharma, Inc. is recalling Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) in 50 mL glass bottles. The affected lot was manufactured at the same facility using the same components as products that had cracked seals in caps, which were found to be superpotent.
The recalled product is Lot #16306 with an expiration date of 01/2024. A total of 7,008 glass bottles have been distributed nationwide within the United States. The product carries NDC 63739-997-64.
Consumers who have received this medication should stop use and contact their healthcare provider or pharmacist for guidance. Healthcare professionals and patients should report any adverse events to the FDA's MedWatch program.
The recalled product
- Product
- LIDOCAINE HYDROCHLORIDE (LIDOCAINE HYDROCHLORIDE)
- Brand
- LIDOCAINE HYDROCHLORIDE
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Solution
- Affected units
- 7,008
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 #: 16306
- Exp. Date 01/2024.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Teligent Pharma, 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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