Teligent Pharma is voluntarily recalling 1 lot of Lidocaine HCl Topical Solution 4%, 50mL in a screw cap glass bottle due to super potency.
Lidocaine HCl Topical Solution is indicated for the production of topical anesthesia of accessible mucous membranes of the oral and nasal cavities and proximal portions of the digestive tract.
The recalled lot, Lidocaine HCl Topical Solution 4% (40mg/mL); NDC# 52565-009-50; Lot# 14218; Exp 9/2022, was distributed at the wholesale and retail distribution levels in the US and Canada.
Depending on the duration of treatment and the specific patient, use of an increased lidocaine dose may lead to local anesthetic systemic toxicity that may result in severe morbidity and mortality if not recognized immediately. To date, the Company has not received any reports of adverse events related to this recall.
Consumers with any product or recall related questions may contact Teligent Pharma at (856) 697-1441 or email Medical@teligent.com.
Adverse events or quality issues should be reported to the Food and Drug Administration’s MedWatch Adverse Event Reporting program.
Teligent Pharma, Inc.’s issues voluntary recall of Lidocaine HCl Topical Solution 4% (Lot # 14218, Exp. 09/2022) due to super potency. News release. US Food and Drug Administration. Accessed September 8, 2021. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teligent-pharma-incs-issues-voluntary-recall-lidocaine-hcl-topical-solution-4-lot-14218-exp-092022.
Source: Medical Bag https://www.medicalbag.com/home/news/lidocaine-hci-topical-solution-recalled-due-to-super-potency/