Search: &quot;burn&quot;

FDAFeb 24, 2023Nationwide• Ecometics, Inc.

Easy Care Burn Cream (GFA) - microbial contamination (2022)

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

FDADec 23, 2022Nationwide• GFA Production Xiamen Co. Ltd.

Vyce World Nutrition Bed Burn Capsules (NutraCap Labs) – undeclared milk (2021)

Undeclared Milk

During an FDA investigation the firm was notified that the product contains undeclared milk.

Class I

FDANov 9, 2021AL, AZ, AR +23 more• NutraCap Labs LLC

Z-Burn Sleep Smart Capsules (NutraCap Labs) – undeclared milk (2021)

Undeclared Milk

During an FDA investigation the firm was notified that the product contains undeclared milk.

FDANov 9, 2021AL, AZ, AR +23 more• NutraCap Labs LLC

Over-the-Counter Drugs (Medique) – Packaging Issue (2020)

CPSCSep 11, 2020Nationwide• Medique, of Fort Myers, Fla.

The recall involves 31 different over-the-counter drugs purchased on or after June 1, 2018 that are unexpired from the following brands: Medi-First, Medi-First Plus, Medique, Dover, Otis Clapp, and Ecolab. They include aspirin-containing products, acetaminophen-containing products, ibuprofen-containing products, lidocaine-containing products, diphenhydramine, loperamide, and naproxen products. The expiration date for tablets and creams can be found on either the top or side panels of the container carton in the format [YEAR/MO]. For products in spray bottles, the expiration date in the same format is located on the front of the bottle. The expiration date is found on the bottom for the spray cans. The 31 different recalled products are listed in the table below: Product Drug Package Type # of Packets Medi-First Non-Aspirin Acetaminophen acetaminophen (325 mg) 2 tablets packet 50 250 Medi-First Extra Strength Non-Aspirin Acetaminophen acetaminophen (500 mg) 2 tablets packet 50 125 250 Medi-First Sinus Pain & Pressure acetaminophen (500 mg) 2 tablets packet 50 125 250 Medique APAP acetaminophen (325 mg) 2 tablets packet 250 Medique Extra Strength APAP acetaminophen (500 mg) 2 tablets packet 50 125 250 Medique Back Pain-Off acetaminophen (250 mg) 2 tablets packet 50 100 250 Medique CCP Caffeine Fee acetaminophen (325 mg) 2 tablets packet 50 250 Medi-First Cold Relief acetaminophen (325 mg) 2 tablets packet 50 125 250 Medique Cramp Tabs acetaminophen (325 mg) 2 tablets packet 50 125 250 Medique Decorel Forte Plus acetaminophen (325 mg) 2 tablets packet 50 250 Medique Medicidin-D acetaminophen (325 mg) 2 tablets packet 50 100 250 Dover Aminofen acetaminophen (325 mg) 2 tablets packet 250 Otis Clapp Back Quell acetaminophen (200 mg) 2 tablets packet 150 Otis Clapp Mygrex acetaminophen (500 mg) 2 tablets packet 150 Otis Clapp Valihist acetaminophen (325 mg) 2 tablets packet 150 Medi-First Pain Relief Extra Strength acetaminophen (110 mg) aspirin (162 mg) 2 tablets packet 50 100 250 Medi-First Plus Pain Zappers acetaminophen (250 mg) aspirin (250 mg) 2 tablets packet 50 125 Medique Pain-Off acetaminophen (250 mg) aspirin (250 mg) 2 tablets packet 50 100 250 Medi-First Aspirin aspirin (325 mg) 2 tablets packet 50 125 250 Medi-First Plus Aspirin aspirin (325 mg) 2 tablets packet 50 125 Medique Aspirin aspirin (325 mg) 2 tablets packet 12 100 250 Medique Diphen diphenhydramine (25 mg) 1 tablet packet 24 200 Medi-First Ibuprofen ibuprofen (200 mg) 2 tablets packet 4 50 125 250 Medique I-Prin ibuprofen (200 mg) 2 tablets packet 3 100 250 Dover Addaprin ibuprofen (200 mg) 2 tablets packet 250 Medi-First Burn Cream with Lidocaine lidocaine (0.9 grams) packets 25 Medi-First Burn Spray lidocaine HCl (2%) 2 oz bottle -- Medi-First Blood Clotting Spray lidocaine (4%) 3 oz bottle -- Ecolab Burn Cream lidocaine (0.9 grams) packets 25 Medique Diamode loperamide HCl (2 mg) 1 tablet packet 6 50 100 Medique Mediproxen naproxen sodium (220 mg) 1 tablet packet 50 100

ALOCANE Emergency Burn Pads (Quest Products) – Child Safety Issue (2019)

CPSCNov 14, 2019Nationwide• Quest Products LLC, of Pleasant Prairie, Wis.

This recall involves the ALOCANE® Emergency Burn Pads (10 count and 15 count) which come in a white and red box with "MAXIMUM STRENGTH ALOCANE® Emergency Burn Pads" printed on the front. The product is an over the counter Gel Infused Pad with lidocaine (4%) as the active ingredient. The pads are sold in a 10 count box and 15 count box with the lot numbers 4179, 4180, 4235, 4645, 4646 or 4698 printed next to the barcode on the box. The UPC number for the affected product is 8-46241-02448-7 and can be found on the bottom of the box.

Life Change Fat Burner (Get The Tea) – Contains Soy (2018)

Get The Tea is notifying customers that Life Change Fat Burners contain soy.

FDAFeb 23, 2018Nationwide• Get The Tea

Burn Relief Gel (Assured) – Safety Packaging (2015)

CPSCDec 10, 2015Nationwide

The recalled burn relief gel is packaged in a blue box with white letters "Burn Relief" and red letters "Burn Relief Gel". The brand name is Assured™. Inside the box is a blue and white tube labeled "Burn Relief Gel" and measuring approximately 5 inches long by 1 inch wide and weighs about 0.7 ounces (20 grams). The packaging contains the UPC bar code: 6 39277 09311 0.

Natureal Burn Fat Nature (Inaffit) – undeclared ingredient (2015)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine.

FDAOct 5, 2015Nationwide• Inaffit, LLC

Thin and Slim Burn Fat Now Dietary Supplement (Novacare) – Unapproved Supplement (2015)

Marketed Without an Approved NDA/ANDA: FDA sampling confirmed the presence of Salicylic acid in dietary supplements.

FDAAug 24, 2015Nationwide• Novacare, LLC

MEGA-BURN Weight Loss Injectable (Compounding Pharmacy) – sterility risk (2015)

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

FDAJun 2, 2015Nationwide• The Compounding Pharmacy of America

MEGA-BURN IV Injectable (Compounding Pharmacy) – sterility risk (2015)

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

FDAJun 2, 2015Nationwide• The Compounding Pharmacy of America

MEGA-BURN Injectable (The Compounding Pharmacy) – Sterility Concerns (2015)

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

FDAJun 2, 2015Nationwide• The Compounding Pharmacy of America

Fat Burning Bomb Capsules (MyNicNaxs) – Undeclared Ingredients (2014)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine

FDAJan 24, 2014Nationwide• MyNicNaxs, Inc.

ROHTO Cooling Eye Drops (Mentholatum) – sterility concern (2014)

Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief and Rohto Cool eye drops, due to concerns related to the quality assurance of sterility controls.

FDAJan 16, 2014Nationwide• The Mentholatum Co.

Burn 7 Capsules (Deseo Rebajar) – Undeclared Substances (2013)

Marketed Without an Approved NDA/ANDA: Undeclared sibutramine and phenolphthalein in Burn 7 dietary supplement

FDADec 23, 2013PR• Deseo Rebajar

Mercuroclear Antiseptic (Humco) – Microbial Contamination (2013)

Microbial Contamination of Non-Sterile Product(s): The product was found to be contaminated with Bulkholderia sp.

FDANov 26, 2013Nationwide• Humco Holding Group, Inc

Mercuroclear Antiseptic First Aid (Humco) – Microbial Contamination (2013)

Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.