Food and Drug Recalls

Date:9/1/2021

Official Message No.:110856-9-1-2021-PHIN

Contact Info:

Attachments: No

Please review the following message from Alan Talarsky, Environmental Scientist 4, Public Health and Food Protection Program, NJDOH regarding the following Class 1 Recalls issued by the U.S. Food and Drug Administration: 1.Rocky Top Farms of Ellsworth, MI, is recalling its 10-ounce jars of "Cherry Butter" fruit butter because they may contain undeclared milk. People who have an allergy or a severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. The recalled "Cherry Butter" was distributed nationwide through the company website (www.rockytopfarms.com). The product comes in a 10-ounce, clear glass jar. All lots are affected with this recall. The product may have been sold individually or in multi-packs or variety packs. No illnesses have been reported to date in connection with this problem. The recall was initiated after it was discovered that the milk containing product was distributed in packaging that did not reveal the presence of milk. Production of the product has been suspended until FDA and the company are certain that the problem has been corrected. Consumers who have purchased 10-ounce jars of "Cherry Butter" that were incorrectly labeled are allowed to return them to the place of purchase for a full refund. If the incorrectly labeled product was purchased through our website, consumers are asked to destroy the product and contact the company for a refund. Consumers with questions may contact the company at 1-231-350-0985, Monday through Friday during 9 a.m.- 5 p.m. ****************************************************************************** 2. KBF Inc. of Astoria, NY, is recalling its 8.11 ounce packages of “Banoful Top Orange Biscuit” food treats because they may contain undeclared milk allergens. Consumers who are allergic to milk allergens may run the risk of serious or life-threatening allergic reactions if they consume this product. The recalled “Banoful Top Orange Biscuit” were distributed nationwide in retail stores and through mail orders. The product comes in an 8.11 ounce, orange plastic package marked with MFG 15.06.2020 on the top and with an expiration date of 14/06/2022 stamped on the side. The product UPC code is 8-941114-001427. No illnesses or allergic reactions involving this product have been reported to date. The recall was initiated after routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of undeclared milk allergens in the 8.11 ounce packages of “Banoful Top Orange Biscuit” which did not declare a milk ingredient on the label. Consumers who have purchased 8.11 ounce packages of “Banoful Top Orange Biscuit” are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-646-714-4062. ****************************************************************************** 3. Teligent Pharma, Inc. is voluntarily recalling one lot of Lidocaine HCl Topical Solution 4%, 50ml in a screw cap glass bottle 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. Risk Statement: 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 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# 52565-009-50. The affected Lidocaine HCl Topical Solution 4% lot number and expiration date are: Lot # 14218, Exp. 09/2022. The product can be identified by the following labeling: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL). Product was distributed at the wholesale and retail distribution levels in the US and Canada. Teligent Pharma, Inc. is notifying its distributors via Fed-Ex and is arranging for return of all recalled products. Distributors, consumers, and patients that have Lidocaine HCl Topical Solution 4% which is being recalled should return product to their place of purchase. Consumers with questions regarding this recall can contact Teligent Pharma, Inc. by phone at 1-856-697-1441 press * to reach the medical information call center Monday through Friday, 8am – 5pm or send an e-mail to Medical@teligent.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. • Complete and submit the report Online • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. ****************************************************************************** No action is required of local health departments at this time for any of these recalls. If any requests for assistance are received from FDA, the Public Health and Food Protection Program will contact you. For additional information regarding warnings and recalls, please click on the weblink below. ****************************************************************************** For all recalls - http://www.recalls.gov/recent.html