Bactine FDA Alerts

FDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health Effects

Mar 26, 2024 | Audience: Consumers

March 26, 2024 -- The U.S. Food and Drug Administration is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. The agency issued warning letters to six companies for marketing these products in violation of federal law.

Some of these products are labeled to contain ingredients, such as lidocaine, at concentrations that are higher than what is permitted for over-the-counter, topical pain relief products. When these products that contain high concentrations of lidocaine intended to be used before or during certain cosmetic procedures are applied in ways that could lead to increased absorption of the drug product through the skin, it may lead to serious injury such as irregular heartbeat, seizures and breathing difficulties. These products may also interact with medications or dietary supplements a consumer is taking.

“These products pose unacceptable risks to consumers and should not be on the market,” said Jill Furman, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “We are committed to using all available tools to stop the sale of these illegal high-risk products.”

Despite FDA warnings to consumers about similar products over the past decade, the agency continues to find potentially dangerous products available online and in retail stores. The FDA is not aware of evidence demonstrating these products are safe.

Additionally, when lidocaine is applied over large areas of skin, particularly on irritated or broken skin, for prolonged periods of time and when the skin is covered, the product may cause serious injury.

The products in the warning letters are:

• TKTX Company: TKTX Numb Maximum Strength Pain Reliever, Mithra+ 10% Lidocaine, TKTX During Procedure Numbing Gel 40% and J-CAIN cream [LIDOCAINE] 29.9%
• SeeNext Venture, Ltd.: NumbSkin 5% Lidocaine Numbing Cream (15 grams), NumbSkin 5% Lidocaine Numbing Cream (30 grams) and NumbSkin 10.56% Lidocaine Numbing Cream
• Tattoo Numbing Cream Co.: Signature Tattoo Numbing Cream and Miracle Numb Spray
• Sky Bank Media, LLC, doing business as Painless Tattoo Co.: Painless Tattoo Numbing Cream and Painless Tattoo Numbing Spray
• Dermal Source, Inc.: New & Improved Blue Gel, Superior Super Juice, Premium Pro Plus, Five-Star Vasocaine and Maximum Zone 1
• Indelicare, doing business as INKEEZE: Ink Eeze Original B Numb Numbing Gel, Ink Eeze B Numb Numbing Spray Black Label and Ink Eeze B Numb Numbing Foam Soap

The FDA recommends consumers:

• not use OTC pain relief products with more than 4% lidocaine on their skin
• not apply OTC pain relief products heavily over large areas of skin or to irritated or broken skin.
• not wrap skin treated with OTC pain relief products with plastic wrap or other dressings. Wrapping or covering treated skin with any type of material can increase the chance of serious side effects.

The FDA is aware of reports of adverse events related to these products and encourages consumers and health care professionals to report any adverse events with use of any drug to the MedWatch Adverse Event Reporting program so the agency can take action to protect the public from any unsafe products.

The FDA has asked the companies to respond to the warning letters within 15 days of receipt stating how they will address these issues or provide their reasoning and supporting information as to why they think the products are not in violation of the law. Failure to address violations promptly may result in legal action, including product seizure and/or a court order requiring a company to stop manufacturing and distributing violative products. Additionally, the agency has placed some of these companies on import alert to help stop their products from entering the U.S. and reaching consumers.

---

Voluntary Recall of Certain Family Dollar Over-the-Counter Products

Jul 21, 2022 | Audience: Consumers

July 21, 2022 -- Family Dollar is initiating a voluntary retail level product recall of certain products regulated by the U.S. Food and Drug Administration (FDA) that were stored and inadvertently shipped to certain stores on or around May 1, 2022 through June 10, 2022 due to product being stored outside of labeled temperature requirements.

To date, Family Dollar has not received any consumer complaints or reports of illness related to this recall.

A list of the recalled products is attached. This recall goes to the retail store level.

Family Dollar has notified its affected stores asking them to check their stock immediately and to quarantine and discontinue the sale of any affected product. Customers that may have bought affected product may return such product to the Family Dollar store where they were purchased without receipt. This recall does not apply to Delaware, Alaska, Hawaii as no Family Dollar stores in Delaware received any products subject to this recall and Family Dollar does not have any stores in Alaska or Hawaii.

Customers with questions regarding this recall may contact Family Dollar Customer Service at 844-636-7687 between 9am and 5pm EST. Customers should contact their physician or health care provider if they have experienced any problems that may be related to using these products.

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: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
• https://www.fda.gov/safety/report-problem-fda

 

List of Recalled Products

Source: FDA

---

Teligent Pharma, Inc. Issues Voluntary Recall of Lidocaine HCl Topical Solution 4% Due to Super Potency

Aug 30, 2021 | Audience: Health Professional, Pharmacy

August 30, 2021 - 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.

Source: FDA

---

Ridge Properties LLC DBA Pain Relief Naturally Issues Voluntary Nationwide Recall of PRE-TAT , Superior Pain and Itch Relief, and Soothing Sore Relief Cream and Gel Products Due to Microbiological Contamination and Superpotency

Aug 8, 2019 | Audience: Consumer, Health Professional, Pharmacy

August 8, 2019 -- Ridge Properties LLC DBA Pain Relief Naturally is voluntarily recalling 4 lots of 4% lidocaine topical cream & liquid gel products sold at the consumer level. FDA analysis has found these products to have microbiological contamination and the potency is higher than the labeled amount for lidocaine.

The risks from a contaminated pre-tattoo product are greater since the skin is being traumatized immediately after application and tattooing is known to have infectious complications. Additionally, use of lidocaine greater than the label claim may increase the risk of methemoglobinemia, a blood disorder in which an abnormal amount of methemoglobin is produced. To date, the company has not received any reports of adverse events related to this recall.

PRE-TAT is marketed as a numbing agent/topical anesthetic used prior to tattoo application. Soothing Sore Relief is marketed for soothing relief of pain and/or itch associated with hemorrhoids and bedsores. Superior pain and itch relief is marketed as a numbing agent/topical anesthetic. Lots & expiration dates are listed on a gold colored expiration sticker on the back of the products. Products were distributed nationwide through online sales at the following websites: amazon.com, ebay.com, walmart.com, tatbalm.net, & naturallyhl.com. These products are used as a topical anesthetic and are packaged in black jars or bottles with metallic red or green lettering. The affected products include the following lot numbers and expiration dates:

The product can be identified by the above stated names and descriptions. Lots & expiration dates are listed on a gold colored expiration sticker on the back of the product. Products were distributed Nationwide through online sales at the following websites: amazon.com, ebay.com, walmart.com, tatbalm.net, & naturallyhl.com. No products from these lots are currently for sale, or in stock at company or any of it's distributors.

Company is notifying its customers by press release, and recall letter and is arranging for replacement of all recalled products. Consumers that have products of the specified lot numbers which are being recalled should stop using, discard or return with recall response form, and reach out to the company for a replacement using the recall response form which can be emailed to prncustomercare@gmail.com, or mailed to the following address.

Pain Relief Naturally Recall Department
4995 Ridge Dr NE
Salem, OR, 97301

Consumers with questions regarding this recall can contact company by phone at (1- 877-906-4806) 9 am - 5 pm Monday-Friday, pacific time, or by email at prncustomercare@gmail.com Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products. A recall response form will be included in recall letter to consumers, or can be printed from www.tatbalm.net or www.naturallyhl.com. Consumers should include the quantity of returned items on the recall response form irregardless of whether products are returned or discarded.

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.

Source: FDA

---

Ridge Properties DBA Pain Relief Naturally Products: Recall - Manufacturing Concerns at the Facility

Nov 6, 2017 | Audience: Consumer, Pharmacy

Including: Naturally HL Bedsore Relief Cream, Extra Strength PreTAT by TAT Balm Carbomer Free Gel, and Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine

[Posted 11/06/2017]

ISSUE: Ridge Properties DBA Pain Relief Naturally is voluntarily recalling all lots within expiry of Naturally HL Bedsore Relief Cream, Extra Strength PreTAT by TAT Balm Carbomer Free Gel, and Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine manufactured by Ridge Properties dba Pain Relief Naturally, to the consumer level. FDA inspection found significant violations of current good manufacturing practice regulations.

Manufacturing practices that are not in adequate control represent the possibility of risk being introduced into the manufacturing process in decreased quality and consistency (i.e., the safety, identity, strength, quality and purity). Ridge Properties has received reports of subpotency in Extra Strength PreTAT by TAT Balm Carbomer Free Gel.

BACKGROUND: The products were distributed nationwide via the internet at amazon.com, ebay.com, naturallyhl.com, and tatbalm.net.

RECOMMENDATION: Ridge Properties DBA Pain Relief Naturally is notifying its distributors and customers by National Press Release and is arranging for return of all recalled products. Consumers that have Naturally HL Bedsore Cream, Pretat by TAT Balm Carbomer Free Gel, & All Naturally HL Hemorrhoid products, which is being recalled should stop using & return directly to Ridge Properties DBA Pain Relief Naturally or discard the products.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• 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

[11/01/2017 - Press Release - Ridge Properties dba Pain Relief Naturally]

---

Sterile Drug Products by Bella Pharmaceuticals: Recall - Lack of Sterility Assurance

Aug 18, 2017 | Audience: Health Care Professionals

[Posted 08/18/2017]

ISSUE: Bella Pharmaceuticals is voluntarily recalling all lots of unexpired sterile drug products due to lack of sterility assurance. The recalled products were distributed to health care facilities nationwide.

Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. To date, Bella Pharmaceuticals has not received any reports of adverse events.
 
BACKGROUND: The affected products include all lots distributed April 17, 2017, to August 10, 2017, remaining within expiry, and they would be packaged in a syringe, vial or eye dropper. For a list of products affected by this recall see the Firm Press Release.

RECOMMENDATION: Bella Pharmaceuticals is notifying its customers by email and phone, and is arranging for the return of all recalled products. Anyone with product subject to the recall should stop using it and contact the company. To return medication or request assistance related to this recall, contact Bella Pharmaceuticals at 877-235-5279, Monday through Friday, between 9 a.m. and 5 p.m. CST.

Health care professionals  are encouraged to report any adverse events to FDA’s MedWatch Adverse Event Reporting Program:

• Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
• 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.

[08/18/2017- Press Release - Bella Pharmaceuticals]

---

Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain

Jun 26, 2014 | Audience: Consumer, Pediatrics, Family Practice

ISSUE: FDA notified health professionals, their provider organizations and caregivers for infants, that prescription oral viscous lidocaine 2% solution should not be used to treat infants and children with teething pain. FDA is requiring a Boxed Warning to be added to the prescribing information (label) to highlight this information. Oral viscous lidocaine solution is not approved to treat teething pain, and use in infants and young children can cause serious harm, including death.

Topical pain relievers and medications that are rubbed on the gums are not necessary or even useful because they wash out of the baby’s mouth within minutes. When too much viscous lidocaine is given to infants and young children or they accidentally swallow too much, it can result in seizures, severe brain injury, and problems with the heart. Cases of overdose due to wrong dosing or accidental ingestion have resulted in infants and children being hospitalized or dying.

BACKGROUND: In 2014, FDA reviewed 22 case reports of serious adverse reactions, including deaths, in infants and young children 5 months to 3.5 years of age who were given oral viscous lidocaine 2 percent solution for the treatment of mouth pain, including teething and stomatitis, or who had accidental ingestions. See further details in the FDA Drug Safety Communication.

RECOMMENDATION: Health care professionals should not prescribe or recommend this product for teething pain. Parents and caregivers should follow the American Academy of Pediatrics’ recommendations for treating teething pain.

• Use a teething ring chilled in the refrigerator (not frozen).
• Gently rub or massage the child’s gums with your finger to relieve the symptoms.

FDA is also encouraging parents and caregivers not to use topical medications for teething pain that are available over the counter (OTC) because some of them can be harmful. FDA recommends following the American Academy of Pediatrics’ recommendations to help lessen teething pain.

For additional information for health professionals and patients, including the full data summary, see the FDA Drug Safety Communication. 
 

[06/26/2014 - Drug Safety Communication - FDA]
[06/26/2014 - Consumer Update - FDA]
 

---

Topical Anesthetics

Jan 16, 2009 | Audience: Consumers, radiological healthcare professionals, emergency room healthcare professionals, risk managers[Posted 01/16/2009] FDA issued a public health advisory to remind patients, healthcare professionals, and caregivers about potentially serious hazards of using skin numbing products, also known as topical anesthetics, for relieving pain from mammography and other medical tests and conditions. FDA is concerned about the potential for these products to cause serious, life-threatening adverse effects, such as irregular heartbeat, seizures, breathing difficulties, coma and even death, when applied to a large area of skin or when the area of application is covered. FDA is working with healthcare professional organizations and other media that distribute healthcare information to spread the message about the potential hazards and safe use of topical anesthetics. The Advisory and the Dear Colleague letter provide recommendations to both doctors and patients on safe use of these products.

[January 16, 2009]

---