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Showing 1361–1380 of 3363 results

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Valsartan Tablets 40mg (Jubilant Cadista) – incorrect excipient (2018)

Undeclared Allergen

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

FDAAug 14, 2018Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Tyvaso Inhalation System (United Therapeutics) – Defective Device (2018)

Defective Delivery System: Water ingress through the lower water cup sensor of the device.

FDAAug 14, 2018IL, PA• United Therapeutics Corp.

Valsartan Tablets (Jubilant Cadista) – Incorrect Excipient (2018)

Undeclared Allergen

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

FDAAug 14, 2018Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Valsartan Tablets (Jubilant Cadista) – Incorrect Excipient (2018)

Undeclared Allergen

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

FDAAug 14, 2018Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Diltiazem HCl Capsules (Mylan) – Impurity Specifications (2018)

Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer

FDAAug 14, 2018Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Valsartan Tablets (Jubilant Cadista) – Incorrect Excipient (2018)

Undeclared Allergen

Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.

FDAAug 14, 2018Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Morton Natural Sea Salt (Morton Salt) – Mislabeled Packaging (2018)

Iodized sea salt was packaged in Morton Natural Sea Salt packages.

FDAAug 9, 2018FL, IN, ME +7 more• MORTON SALT INC

Contrave Tablets (Orexigen) – Defective Container (2018)

Defective Container: Customer complaints of punctures in the bottle.

FDAAug 9, 2018Nationwide• Orexigen Therapeutics, Inc.

Azelastine HCl Eye Drops (Akorn) – Impurity Specification (2018)

Failed Impurities/Degradation Specifications:out-of-specification (OOS) results for Azelastine N-oxide

FDAAug 8, 2018Nationwide• Akorn, Inc.

Diltiazem HCl Capsules (Mylan) – Stability Test Failure (2018)

Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.

FDAAug 7, 2018Nationwide• Mylan Pharmaceuticals Inc.

Diltiazem HCl Capsules (Mylan) – Stability Test Failure (2018)

Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.

FDAAug 7, 2018Nationwide• Mylan Pharmaceuticals Inc.

Cicatricure Scar Cream SPF 30 (Product Quest) - Ingredient Potency Issue (2018)

Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.

FDAAug 3, 2018Nationwide• Product Quest Manufacturing LLC

Acne Treatment Pads (Huijing) – Active Ingredient Variance (2018)

Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.

FDAAug 3, 2018IN, VA• Huijing (Shanghai) Bio-tech Co., Ltd.

Virt-Nate Tablets (Virtus Pharmaceuticals) – Product Safety Issue (2018)

Virtus Pharmaceuticals, LLC has decided to initiate a recall of the following products : Virt-Nate Tablets and Virt Gard Tablets because product labels do not reflect the correct amount of Dietary Folate Equivalents (DFEs) calculated based on the product formulation.

FDAAug 3, 2018AZ, CA, CO +23 more• VIRTUS PHARMACEUTICALS LLC.

Virt Gard Tablets (Virtus Pharmaceuticals) – Product Safety Issue (2018)

Virtus Pharmaceuticals, LLC has decided to initiate a recall of the following products : Virt-Nate Tablets and Virt Gard Tablets because product labels do not reflect the correct amount of Dietary Folate Equivalents (DFEs) calculated based on the product formulation.

FDAAug 3, 2018AZ, CA, CO +23 more• VIRTUS PHARMACEUTICALS LLC.

Walgreens Scar Cream SPF 30 (Product Quest) - Ingredient Potency Issue (2018)

Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.

FDAAug 3, 2018Nationwide• Product Quest Manufacturing LLC

Atorvastatin Calcium Tablets 40mg (Dr. Reddy's) – Impurity Specification Failure (2018)

Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.

FDAAug 2, 2018Nationwide• Dr. Reddy's Laboratories, Inc.

Levofloxacin Injection 250mg (Baxter) – Superpotent Drug Risk (2018)

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

FDAAug 1, 2018Nationwide• Baxter Healthcare Corporation

Levofloxacin Injection 750mg (Baxter) – Superpotent Drug Risk (2018)

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

FDAAug 1, 2018Nationwide• Baxter Healthcare Corporation

Levofloxacin Injection 500mg (Baxter) – Superpotent Drug Risk (2018)

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

FDAAug 1, 2018Nationwide• Baxter Healthcare Corporation

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