Medicine recalls
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| The United States: Teligent Pharma, Inc. issues worldwide voluntary recall of Lidocaine HCl Topical Solution 4% due to super potency |
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The US Food and Drug Administration (FDA) announces that Teligent Pharma, Inc. is voluntarily recalling 5 lots of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle (lot number: 13262, 14217, 13058, 13768, 16306) to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specification (OOS) result obtained at the 18-month stability timepoint.
Use of the super potent product would result in a higher than intended lidocaine dose above that intended. An increased lidocaine dose could lead to the development of local anesthetic systemic toxicity depending on the duration of the treatment and the specific patient. Local anesthetic systemic toxicity can result in central nervous system reactions including excitation and/or depression and more serious signs of cardiovascular toxicity, such as bradycardia, hypotension, and even cardiovascular collapse can present very quickly. If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result. Adults and the elderly who are more likely to use this product as well as children of lower body weight are more likely to experience local anesthetic systemic toxicity if a higher than intended lidocaine concentration is administered. To date, Teligent Pharma, Inc. has not received any reports of adverse events related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teligent-pharma-incs-issues-worldwide-voluntary-recall-lidocaine-hcl-topical-solution-4-due-super
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by Health Canada and FDA, and was posted on the Drug Office website on 13 Aug 2021 and 31 Aug 2021.
Ends/Friday, Oct 15, 2021
Issued at HKT 16:00
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