Lidocaine Hydrochloride Topical Solution Recalled for Superpotency
Teligent Pharma is recalling Lidocaine Hydrochloride Topical Solution, USP 4% due to the product being superpotent. The recall affects 32,544 bottles distributed nationwide in the United States and Canada.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I, which mandates a minimum severity score of 4 per the rubric. A superpotent drug carries inherent risk of patient harm through overdosage or excessive effects, even without reported illnesses in the source text.
Plain-English summary
Teligent Pharma, Inc., located in Buena, New Jersey, is voluntarily recalling Lidocaine Hydrochloride Topical Solution, USP, 4%, in 50 mL glass bottles (NDC 52565-009-50). The recall was initiated due to the product being superpotent.
Approximately 32,544 glass bottles were distributed nationwide within the United States and Canada. The affected lot is Lot #14218 with an expiration date of 08/2022.
Consumers and healthcare providers who have this product should stop using it and consult with a healthcare provider regarding alternative treatment options. The FDA classified this as a Class I recall on September 15, 2021. For additional information, patients should contact their healthcare provider or pharmacist.
The recalled product
- Product
- Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Anesthetic
- Affected units
- 32,544
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 #:14218
- Exp. Date 08/2022
Distribution
Distributed nationwide across the United States.
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