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Showing 641–660 of 2521 results

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SkinGuard Hand Sanitizer – Unapproved Formulation (2020)

Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug

FDAAug 14, 2020Nationwide• SG24 LLC

Florance Morris Hand Sanitizer (Grupo Asimex) – Chemical Contamination (2020)

Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.

FDAAug 14, 2020Nationwide• Grupo Asimex de Mexico SA de CV

Florance Morris Hand Sanitizer (Grupo Asimex) – Manufacturing Issues (2020)

CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.

Class IIModerate

FDAAug 14, 2020Nationwide• Grupo Asimex de Mexico SA de CV

Hand Sanitizer Foam Pump (SG24 LLC) - Unapproved Methanol Drug (2020)

Marketed without an Approved NDA/ANDA; product labeled to contain 0.56% methanol making it an unapproved new drug

FDAAug 14, 2020Nationwide• SG24 LLC

Thule Sleek Strollers – Injury Hazard (2020)

This recall involves Thule Sleek strollers. The recalled strollers were sold in black, dark gray, light gray, navy blue and red with a silver or black frame. Only strollers without a QC2020 sticker next to the product label and manufactured between May 2018 through September 2019 are included in this recall. The manufacture date code in YY/MM format, Thule Sleek and product number: 11000001-5, 11000017, 11000330 or 11000337-342 can be found on the product label located on the lower inside frame of the stroller. UPC code 091021978485, 091021883703, 091021460256, 091021761773, 091021079779, 091021070585, 091021349001, 091021433137, 091021514386, 091021037090,091021091900, 091021648937 or 091021190214 can be found on the product packaging.

CPSCAug 12, 2020Nationwide

Gelbac T Hand Gel (Incredible Products) – methanol contamination (2020)

Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for ethanol.

FDAAug 6, 2020CA, GA• Incredible Products, SA de CV

X-14 Mildew Stain Remover (Spartan) – skin irritation (2020)

This recall involves includes only the 16 and 32 ounce bottles of X-14 Mildew Stain Remover. The recalled bottles have a lot code between 20052 O and 20127 O, which can be found on the back of the bottle. X-14 Mildew Stain Remover is a bathroom cleaning product used to remove mildew and stains from grout, tile, vinyl, and plastic surfaces. X-14 Mildew Stain Remover is printed on the front of the blue plastic spray bottle. Bottle Size Lot Code on Back of Bottle UPC 16 ounce 20052 O - 20063 O 041737260015 32 ounce 20062 O - 20127 O 041737260763

CPSCAug 5, 2020Nationwide• Spartan Chemical Company Inc., of Maumee, Ohio

Day & Night Ear Itch MD Spray (Eosera) – manufacturing deviation (2020)

cGMP Deviations.

Class IIModerate

FDAAug 4, 2020Nationwide• Eosera, Inc.

GelAnti Bac Hand Sanitizer (Roque Plast) – methanol risk (2020)

Undeclared Allergen

CGMP Deviation: Potential contamination with undeclared methanol.

Class IIModerate

FDAAug 4, 2020Nationwide• ROQUE PLAST, S.A. DE C.V.

Ear Itch MD Spray (Eosera) – manufacturing deviation (2020)

cGMP Deviations.

Class IIModerate

FDAAug 4, 2020Nationwide• Eosera, Inc.

Alcohol Antiseptic Solution (Leiper's Fork) – methanol labeling (2020)

Labeling Not Elsewhere Classified: Product labeled to contain methanol.

Class IIModerate

FDAAug 3, 2020TN• Leiper's Fork Distillery

Red Cross Oral Pain (Mentholatum) – labeling error (2020)

Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.

FDAJul 31, 2020Nationwide• The Mentholatum Company

Next Advanced Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

Modesa Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

NuuxSan Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

Assured Hand Sanitizer (Albek De Mexico) – ethanol contamination (2020)

CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 30, 2020Nationwide• Albek De Mexico S.A. De C.V.

Hand Sanitizer Gel 70% (Resource Recovery) – cGMP Deviation (2020)

cGMP deviations

Class IIModerate

FDAJul 27, 2020AL, GA• RESOURCE RECOVERY & TRADING LLC

Herbacil Hand Sanitizer (Broncolin) – Manufacturing Facility Issue (2020)

CGMP Deviations: products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 27, 2020Nationwide• Broncolin, S.A. de C.V.

Herbacil Hand Sanitizer (Broncolin) – Ethanol Content Deviation (2020)

Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below the label claim for ethanol content and contained methanol.

FDAJul 27, 2020Nationwide• Broncolin, S.A. de C.V.

Born Basic Anti-Bac Hand Sanitizer (Real Clean) – Alcohol Content Problem (2020)

CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.

Class IIModerate

FDAJul 23, 2020Nationwide• Real Clean Distribuciones SA de CV

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