Enoxaparin Sodium for Injection Lot SAB06761A was shipped to customers in the months of September and October 2021. A portion of lot SAB06761A experienced a temperature excursion during. (“Sandoz”) is initiating a recall of one lot (SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes to the consumer level. Product recalled: Lidocaine HCl Topical Solution USP 4%, 50mlįOR IMMEDIATE RELEASE – Decem– Princeton, NJ, Sandoz Inc. This recall is being conducted with the knowledge of the U.S. Product was distributed at the wholesale and retail distribution levels nationwide in the US.Ĭonsumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. The product can be identified by the following labeling: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL). The product 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 and is packaged in a 50ml glass bottle with a screw cap with the identification NDC 63739-997-64. Product: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50mL bottle
has not received any reports of adverse events related to this recall. 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. If local anesthetic systemic toxicity is not recognized and treated quickly, severe morbidity and even death can result.
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. 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. Risk Statement: Use of the super potent product would result in a higher than intended lidocaine dose above that intended. See More found it to be super potent based on an Out of Specification (OOS) result obtained at the 9-month (Lot 16345) and 18-month (Lot 15594) stability timepoint. The product is being recalled because the firms testing has. is voluntarily recalling two lots of Lidocaine HCl Topical Solution USP 4%, 50ml in a screw cap glass bottle listed below to the user level.
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