Apicaine-X FDA Alerts
The FDA Alerts below may be specifically about Apicaine-X or relate to a group or class of drugs which include Apicaine-X.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Recent FDA Alerts for Apicaine-X
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
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:
|PreTAT in Cream by TAT BALM 3 in 1 Pre-Tattoo Prep with Lidocaine||1222||06/14/23||1,2, & 4 ounce jars||black jars with metallic red lettering||Amazon.com
|PreTAT in Liquid Gel by TAT BALM 3 in 1 Pre-Tattoo Prep with Lidocaine||1213||06/05/23||1,2, & 4 ounce jars||black jars with metallic red lettering||Amazon.com
|Superior Pain & Itch Releif in Cream||1222||06/14/23||1,2, & 4 ounce jars||black jars with metallic green lettering||Amazon.com
|Superior Pain & Itch Releif in Liquid Gel||1213||06/05/23||1,2, & 4 ounce jars||black jars with metallic green lettering||Amazon.com
|Soothing Sore Releif in Cream Fast Acting of Pain and Itching Associated with Minor Sores in Cream||1228||06/21/23||1,2, & 4 ounce jars||black jars with metallic green lettering||Amazon.com
|Soothing Sore Releif In Liquid Gel Fast Acting Releif of Pain and Itching Associated with Minor Sores in Liquid Gel||1135||12/27/22||1,2, & 4 ounce jars||black jars with metallic green lettering||Amazon.com
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 email@example.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 firstname.lastname@example.org 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.
Ridge Properties DBA Pain Relief Naturally Products: Recall - Manufacturing Concerns at the Facility
Including: Naturally HL Bedsore Relief Cream, Extra Strength PreTAT by TAT Balm Carbomer Free Gel, and Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine
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
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
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.
Topical Anesthetics[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]