Lidocaine Topical Solution Recalled for Superpotency
Teligent Pharma, Inc. is recalling Lidocaine Hydrochloride Topical Solution USP 4% nationwide due to the drug being superpotent. Affected lots are 13262 (Exp. 03/2022) and 14217 (Exp. 08/2022).
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA's Class I classification applies, which mandates a minimum severity score of 4 per the rubric. Although no specific injuries or hospitalizations are reported in the source text, a superpotent drug product carries inherent risk of serious harm, meeting the Severe category threshold.
Plain-English summary
Teligent Pharma, Inc. is recalling Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) in 50 mL glass bottles nationwide. The firm initiated this voluntary recall because the affected drug product has been determined to be superpotent. A total of 52,104 glass bottles are affected, with NDC 52565-009-50.
The affected lot numbers are 13262 with an expiration date of 03/2022 and lot 14217 with an expiration date of 08/2022. The product is a prescription-only topical anesthetic solution.
Patients and healthcare providers who have received this product should contact Teligent Pharma, Inc. or their healthcare provider for guidance. The FDA classified this as a Class I recall, indicating a situation in which there is a reasonable probability that the use of, or exposure to, the product will cause serious adverse health consequences or death.
The recalled product
- Product
- Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
- Manufacturer
- Teligent Pharma, Inc.
- Category
- Drug — Topical Anesthetic
- Hazard
- superpotency
- dosage-error
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 (4)
- Lot #: 13262
- Exp. 03/2022
- 14217
- Exp. 08/2022
Distribution
Distributed nationwide across the United States.
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