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Showing 601–620 of 2521 results

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Real Alkalized Water (Real Water) – liver failure (2021)

Laceration Risk

FDA was notified of cases of acute liver failure after consumption of Real Water

FDAMar 17, 2021Nationwide• Real Water, Inc.

INTEGRA 325/40/3mg Tablets (Cardinal Health) – temperature deviation (2021)

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Class IIModerate

FDAMar 15, 2021FL, GA, SC• Cardinal Health Inc.

China-Gel (China Gel) – contamination risk (2021)

CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.

Class IIModerate

FDAMar 10, 2021Nationwide• China Gel Inc

Aulief Pain Relief (China Gel) – contamination risk (2021)

CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.

Class IIModerate

FDAMar 10, 2021Nationwide• China Gel Inc

Durisan Antimicrobial Solutions (Sanit) – manufacturing deviation (2021)

CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated.

Class IIModerate

FDAMar 10, 2021Nationwide• Sanit Technologies, LLC dba Durisan

China-Gel White (China Gel) – contamination risk (2021)

CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.

Class IIModerate

FDAMar 10, 2021Nationwide• China Gel Inc

Durisan Hand Sanitizer (Sanit) – microbial contamination (2021)

Microbial Contamination of Non-Sterile Products: firm's internal testing found certain lots of the product to be contaminated with Burkholderia contaminans and/or yeast and mold.

FDAMar 10, 2021Nationwide• Sanit Technologies, LLC dba Durisan

Heal the World Hand Sanitizer (PNHC) – misleading packaging (2021)

Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.

FDAMar 10, 2021CA, FL• PNHC, LLC.

KeVita Cucumber Rosemary (Tropicana) – Mislabeling Issue (2021)

Firm initiated a recall because of mislabeling of bottled product inside case.

Class IIModerate

FDAFeb 4, 2021FL, GA, IN +9 more• Tropicana Products, Inc.

Scott Hand Sanitizer (Kimberly-Clark) – label error (2021)

Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer

Class IIModerate

FDAFeb 1, 2021Nationwide• Kimberly-Clark Corporation

Cloud Island Infant Rompers – Choking Hazard (2020)

This recall includes the Cloud Island Waterfront Baby Boutique Romper, Cloud Island Little Peanut and True Navy Rompers, Cloud Island Little Wildflower and Joyful Mint Rompers, Cloud Island Oh Honeybee and Pink Rompers, and Cloud Island Floral Fields and Mint Rompers. The rompers were sold in sizes newborn to 12M. The product item number is printed on the white tag inside of the rompers. Rompers with the following product item numbers are included in the recall: Item Number Item Description 206-05-1379 Cloud Island Waterfront Baby Boutique Romper Newborn 206-05-1380 Cloud Island Waterfront Baby Boutique Romper 0-3 Months 206-05-1381 Cloud Island Waterfront Baby Boutique Romper 3-6 Months 206-05-1382 Cloud Island Waterfront Baby Boutique Romper 6-9 Months 206-05-1383 Cloud Island Waterfront Baby Boutique Romper 12 Months 206-05-1384 Cloud Island Little Peanut and True Navy Rompers Newborn 206-05-1385 Cloud Island Little Peanut and True Navy Rompers 0-3 Months 206-05-1386 Cloud Island Little Peanut and True Navy Rompers 3-6 Months 206-05-1387 Cloud Island Little Peanut and True Navy Rompers 6-9 Months 206-05-1388 Cloud Island Little Peanut and True Navy Rompers 12 Months 206-05-1394 Cloud Island Little Wildflower and Joyful Mint Rompers Newborn 206-05-1395 Cloud Island Little Wildflower and Joyful Mint Rompers 0-3 Months 206-05-1396 Cloud Island Little Wildflower and Joyful Mint Rompers 3-6 Months 206-05-1397 Cloud Island Little Wildflower and Joyful Mint Rompers 6-9 Months 206-05-1398 Cloud Island Little Wildflower and Joyful Mint Rompers 12 Months 206-05-3740 Cloud Island Oh Honeybee and Pink Rompers Newborn 206-05-3741 Cloud Island Oh Honeybee and Pink Rompers 0-3 Months 206-05-3742 Cloud Island Oh Honeybee and Pink Rompers 3-6 Months 206-05-3743 Cloud Island Oh Honeybee and Pink Rompers 6-9 Months 206-05-3744 Cloud Island Oh Honeybee and Pink Rompers 12 Months 206-05-5920 Cloud Island Floral Fields and Mint Rompers Newborn 206-05-5921 Cloud Island Floral Fields and Mint Rompers 0-3 Months 206-05-5922 Cloud Island Floral Fields and Mint Rompers 3-6 Months 206-05-5923 Cloud Island Floral Fields and Mint Rompers 6-9 Months 206-05-5924 Cloud Island Floral Fields and Mint Rompers 12 Months

CPSCDec 30, 2020Nationwide

Cat & Jack Infant Rashguard Swimsuits – Choking Risk (2020)

This recall includes the Cat & Jack "Summer Blue Lemon," "Coral Icon Story Hawaiian," and "Moxie Peach Lemon" one-piece Rashguards infant-toddler swimsuits in sizes 12M to 5T. The Rashguards have snaps that can break or detach. The product's item number is located on the white tag inside of the suit. Products with the following item numbers are included in the recall: Item Number Product Name 328-04-0574 Cat & Jack Summer Blue Lemon One-Piece Rashguard 12M 328-04-0575 Cat & Jack Summer Blue Lemon One-Piece Rashguard 18M 328-04-0576 Cat & Jack Summer Blue Lemon One-Piece Rashguard 2T 328-04-0577 Cat & Jack Summer Blue Lemon One-Piece Rashguard 3T 328-04-0578 Cat & Jack Summer Blue Lemon One-Piece Rashguard 4T 328-04-0579 Cat & Jack Summer Blue Lemon One-Piece Rashguard 5T 328-04-0628 Cat & Jack Coral Icon Story Hawaiian One-Piece Rashguard 12M 328-04-0629 Cat & Jack Coral Icon Story Hawaiian One-Piece Rashguard 18M 328-04-0630 Cat & Jack Coral Icon Story Hawaiian One-Piece Rashguard 2T 328-04-0631 Cat & Jack Coral Icon Story Hawaiian One-Piece Rashguard 3T 328-04-0632 Cat & Jack Coral Icon Story Hawaiian One-Piece Rashguard 4T 328-04-0633 Cat & Jack Coral Icon Story Hawaiian One-Piece Rashguard 5T 328-04-0664 Cat & Jack Moxie Peach Lemon One-Piece Rashguard 12M 328-04-0665 Cat & Jack Moxie Peach Lemon One-Piece Rashguard 18M 328-04-0666 Cat & Jack Moxie Peach Lemon One-Piece Rashguard 2T 328-04-0667 Cat & Jack Moxie Peach Lemon One-Piece Rashguard 3T 328-04-0668 Cat & Jack Moxie Peach Lemon One-Piece Rashguard 4T 328-04-0669 Cat & Jack Moxie Peach Lemon One-Piece Rashguard 5T

CPSCDec 30, 2020Nationwide

Hand Sanitizer (Shane Erickson) – Ethanol Deviation (2020)

CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.

Class IIModerate

FDADec 23, 2020Nationwide• Shane Erickson Inc

ManukaGuard Nasal Spray (NDAL) – Microbial Contamination (2020)

Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast

FDADec 17, 2020Nationwide• NDAL Mfg Inc.

Graco Inclined Sleeper Accessory – Suffocation Risk (2020)

This recall involves the inclined sleeper accessory sold with the Graco Pack 'n Play Day2Dream Playard with Bedside Sleeper, Graco Pack 'n Play Nuzzle Nest Playard, Graco Pack 'n Play Everest Playard and Graco Pack 'n Play Rock 'n Grow Playard with the following model numbers. The model number is located on a label on the underside of the playard on one of the tubes. The inclined sleeper accessory is the only portion of the product that is being recalled. Consumers can continue to use the playard, changing station and bassinet portions of the products without the inclined sleeper accessory according to owner's manual. Product Name Model Numbers Affected Graco Pack 'n Play Day2Dream Playard & Bedside Sleeper 2034085, 2048753 and 2053215 Graco Pack 'n Play Nuzzle Nest Playard 1947177 and 1896392 Graco Pack 'n Play Everest Playard 1946902 and 1946903 Graco Pack 'n Play Rock 'n Grow Playard 2105055

CPSCDec 16, 2020Nationwide

Western Chief Toddler Boots – Choking Hazard (2020)

This recall includes the Western Chief "Abstract Camo," "Alia Silver," and "Sweetheart Navy" Light-Up Rain Boots in sizes 5-12 for toddlers or children. The recalled boots are camouflage, silver glitter, and navy with hearts; include boot handles; and have a light up feature in the heel of the boot. The rivets used to attach the handles are silver-gray in color. "Western Chief" and the model numbers are located on the inside tag of the boot. The recalled model numbers are T24121725P, T24121728P, and T24121729P.

CPSCDec 9, 2020Nationwide• Washington Shoe Company, of Kent, Wash.

Pristine Hand Sanitizer Gel (GAZA) – cGMP Deviation (2020)

cGMP deviations: Product made at the same facility where product tested was sub-potent.

Class IIModerate

FDADec 1, 2020TX• GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALIMENTACION

+Protec Hands Sanitizer (Simex Logistics) – Subpotent Drug (2020)

Subpotent drug

Class IIModerate

FDANov 25, 2020CA, GA, NV +1 more• Simex Logistics SA de CV

CitruGel Hand Sanitizer (Simex Logistics) – Subpotent Drug (2020)

Subpotent drug

Class IIModerate

FDANov 25, 2020CA, GA, NV +1 more• Simex Logistics SA de CV

Baby Feeding Sets (Herobility) – Choking Hazard (2020)

This recall involves Eco Baby Spoons and Forks and Eco Feeding Spoons, as well as the Eco Placemat Feeding sets 4 PCS, because they include the Eco Feeding Spoon. The recalled spoons and forks are made entirely of a plastic compound, and are distinct from the other Herobility spoons and forks sold in the U.S., which consist of plastic handles with steel implements. The Herobility name and, in most instances, the date (month/2019) are located directly on the underside of the recalled products. In addition to products with a date stamp of (month/2019), products with no date stamp are included in the recall.

CPSCNov 25, 2020Nationwide• Herobility AB, of Sweden

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