Clasen Quality Chocolater, Inc Recalls

Chocolate may contain undeclared peanut residue.

FDAJan 18, 2023CA, CO, IL +9 more• Clasen Quality Chocolater, Inc

Semisweet Chocolate Wafer (Clasen Quality) – undeclared peanut (2023)

Chocolate may contain undeclared peanut residue.

FDAJan 18, 2023CA, CO, IL +9 more• Clasen Quality Chocolater, Inc

DF FT Simple Free Dark Wafer (Clasen) - peanut contamination (2023)

Chocolate may contain undeclared peanut residue.

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Class IIILow

FDAJan 18, 2023CA, CO, IL +9 more• Clasen Quality Chocolater, Inc

Simply Free Semisweet Chocolate Drop (Clasen Quality) – undeclared peanut (2023)

Chocolate may contain undeclared peanut residue.

FDAJan 18, 2023CA, CO, IL +9 more• Clasen Quality Chocolater, Inc

Semisweet Baking Drop (Clasen Quality) – undeclared peanut (2023)

Chocolate may contain undeclared peanut residue.

FDAJan 18, 2023CA, CO, IL +9 more• Clasen Quality Chocolater, Inc

DF FT Simple Free White Wafer (Clasen) - peanut contamination (2023)

Chocolate may contain undeclared peanut residue.

FDAJan 18, 2023CA, CO, IL +9 more• Clasen Quality Chocolater, Inc

Semisweet Chocolate Wafer (Clasen) - peanut contamination (2023)

Chocolate may contain undeclared peanut residue.

FDAJan 18, 2023CA, CO, IL +9 more• Clasen Quality Chocolater, Inc

Techni-Care Chloroxylenold (Consolidated) - CGMP Violation (2023)

CGMP Deviations: initiated due to violations of CGMP manufacturing practices

FDAJan 10, 2023Nationwide• Consolidated Chemical, Inc

Humatrix Microclysmic Gel (Consolidated) - CGMP Violation (2023)

CGMP Deviations: initiated due to violations of CGMP manufacturing practices

FDAJan 10, 2023Nationwide• Consolidated Chemical, Inc

Gore Cardioform Septal Occluder (Gore) – Quality Documentation (2022)

Septal Occluders released with incomplete quality test documentation that assesses the release of the device from the delivery system during the index procedure. A potential failure of this quality test could potentially result could result in occluder embolization, anoxic brain injury, central venous or arterial perforation or rupture.

Very High

FDADec 14, 2022Nationwide• W L Gore & Associates, Inc.

Iohexol Injection (BayCare) – Mislabeled Strength (2022)

Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL

Class IHigh

FDADec 1, 2022FL, IN• BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy

ActiveAid 922 Chair (Altimate Medical) – Frame Foldability Issue (2022)

Device manufactured with a component with affects the foldability of the frame, not allowing it to be secured by the frame strap in the folded position.

Moderate

FDANov 30, 2022Nationwide• Altimate Medical, Inc.

Natus Cranial Access Kit (Natus) – Recalled Surgical Drapes (2022)

Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the adhesive component is difficult to remove without damaging the product and may render the product unusable.

Moderate

FDANov 18, 2022Nationwide• Natus Medical Incorporated

AQUACEL Foam Ag Adhesive (ConvaTec) – Visual Contamination (2022)

ConvaTec are voluntarily recalling a batch of AQUACEL Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.

Low

FDANov 15, 2022Nationwide• ConvaTec, Inc

Phenoxybenzamine Capsules (Par) – Failed Impurity Test (2022)

Failed Impurities/Degradation Specifications

FDANov 10, 2022Nationwide• Par Formulations Private Limited

Chocolate Chip Cookie Dough (Nestle) - Foreign Material (2022)

Potential of foreign material within product.