Recall

All recalls8,501 total

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French Broad Chocolate Factory — french broad CHOCOLATE bette's bake sale (a multi-flavor bonbon assortment). 6-piece NET WT. 2.5 OZ (70.75G); 12-piece NET WT. 5 OZ (141.75G); and 24-piece NET WT. 10

Undeclared nut allergen (walnut) due to mislabeling. The product's printed tasting guide incorrectly identifies the Walnut Fudge and Peach Cobbler flavor chocolates (bonbons). Consumers relying on the printed materials could mistakenly consume a nut-containing bonbon.

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Wellnov Supplements LLC — Liposomal Mens 50+ Liquid Multivitamin Drops. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.

Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.

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Wellnov Supplements LLC — Liposomal Prenatal+Postnatal Liquid Multivitamin Drops - Iron Free. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225

Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.

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Wellnov Supplements LLC — Liposomal Collagen Booster. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.

Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.

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Wellnov Supplements LLC — Liposomal Women's Liquid Multivitamin Drops with Iron. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.

Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.

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Wellnov Supplements LLC — Liposomal D3+B12 Spray. Dosage: 3 sprays Liquid. Packaging: Aluminum bottle. 30 ml. Firm Address: VitaminAlly LLC Chandler, AZ 85225.

Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.

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Wellnov Supplements LLC — Liposomal Women's Liquid Multivitamin Drops - Iron Free. Dosage: 3ml Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.

Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.

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Wellnov Supplements LLC — Liposomal Womens 50+ Liquid Multivitamin Drops. Dosage: 3ml Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.

Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.

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Wellnov Supplements LLC — Liposomal Mens Liquid Multivitamin Drops. Dosage: 3mL Liquid. Packaging: Aluminum bottle. 90 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.

Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.

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Joy Gourmet Foods LLC. — Joy Orange Lassi 16 oz.

Product not adequately pasteurized

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Wellnov Supplements LLC — Joint Nourish. Dosage:2 tablespoons (30mL). Liquid. For Oral use. Packaging: Plastic Bottle. Net Volume:480 ml. Firm Address: VitaminAlly LLC Chandler, AZ 85225.

Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen contamination and possible C. Botulinum concerns.

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Wellnov Supplements LLC — Liposomal D3-5000IU Spray Dosage: 3 sprays Liquid. Packaging: Aluminum bottle. 30 ml. Firm Address: Vitaminally LLC Chandler, AZ 85225.

Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.

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Joy Gourmet Foods LLC. — Joy Mint Lassi 16 oz.

Product not adequately pasteurized

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Joy Gourmet Foods LLC. — Joy Salty Lassi 16 oz.

Product not adequately pasteurized

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Joy Gourmet Foods LLC. — Joy Peach Lassi 16 oz.

Product not adequately pasteurized

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Wellnov Supplements LLC — FulviLife Complex. Dosage:2 tablespoons (30mL). Liquid. Packaging: Plastic Bottle. Net Volume:16 fl oz (480 ml). Firm Address: VitaminAlly LLC Chandler, AZ 85225.

Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.

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Thea Pharma, Inc. — Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

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Thea Pharma, Inc. — iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 82584-700-11

Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

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Covidien LLC — Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Numbe

Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

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Novapproach Spine, LLC — OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm, 010-107-1007-2/Small 7 Degree 10mm X 7mm - Oblique, 010-107-1209/Small 7 Degree 12mm X 9mm,

Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.

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Intuitive Surgical, Inc. — Da Vinci ASSY, PSS, SP1098, Part Number: 380601

Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would prevent E-brake engagement and may result in uncontrolled motion. In addition, if it moves/backs out it may cause restricted column range of motion and/or uncontrolled motion, which may cause patient tissue injury/crushing injury/bleeding.

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BioFire Diagnostics, LLC — BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit.

Contamination to in-vitro diagnostic test may result in false positives.

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Bolton Medical Inc. — RelayPro Thoracic Stent-Graft System (various sizes) Reference numbers: 28-N4-32-104-32U 28-N4-32-164-28U 28-N4-32-164-32U 28-N4-32-209-28U 28-N4-32-209-32U 28-N4-32-259-32U 28-

Labeling update concerning proximal clasp disconnection from the outer control tube which may prevent stent graft from being released from the delivery system.

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