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Showing 1521–1540 of 3363 results

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Diet Pepsi (Pepsico) – labeling discrepancy (2018)

Primary package is properly labeled with Aspartame containing liquid but the outer wrap states Aspartame Free.

FDAMar 14, 2018CT, ME, MA +1 more• Pepsico Inc

Psoriasin Relief Cream (Alva-Amco) – Subpotent Coal Tar (2018)

Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.

FDAMar 9, 2018Nationwide• Alva-Amco Pharmacal Companies., Inc.

Triamcinolone Acetonide Lotion (Akorn) – Impurity Specification (2018)

Failed Impurities/Degradation Specifications: High out of specification results for an impurity.

Class IIILow

FDAMar 9, 2018Nationwide• Akorn, Inc.

Clocortolone Pivalate Cream (Dr. Reddy's) – Viscosity Failure (2018)

Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.

FDAMar 8, 2018Nationwide• Dr. Reddy's Laboratories, Inc.

Brilliant Blue G Injection (Pine Pharmaceuticals) – Labeling Mix-Up (2018)

Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.

FDAMar 5, 2018NY• Pine Pharmaceuticals, LLC

Decitabine Injection (InvaGen) – Impurity Specifications (2018)

Failed impurities/degradation specifications: Failure to water content and impurity

FDAMar 5, 2018Nationwide• InvaGen Pharmaceuticals, Inc.

Hydrocodone Bitartrate and Homatropine (Novel) – Impurity Specification (2018)

Failed Impurities/Degradation Specifications

FDAMar 5, 2018Nationwide• Novel Laboratories, Inc.

Flucanazole Injection (Renaissance) – Superpotent and Unstable (2018)

Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability

FDAMar 2, 2018Nationwide• Renaissance Lakewood, LLC

Methylphenidate Hydrochloride (Osmotica) – Subpotent Dosage (2018)

Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.

FDAFeb 28, 2018Nationwide• Osmotica Pharmaceutical Corp

Lynparza (AstraZeneca) – Elevated Impurity (2018)

Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).

FDAFeb 23, 2018Nationwide• AstraZeneca Pharmaceuticals LP

Labetalol HCl Injection (SCA) – Incorrect Labeling (2018)

Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018

FDAFeb 22, 2018GA, NE, PA• SCA Pharmaceuticals, LLC.

Godis Paskkyckling Marshmallow (Ikea) – Pest Contamination (2018)

Possible Pest Contamination at production facility.

FDAFeb 22, 2018Nationwide• Ikea North America Srvcs Inc

Atropine Sulfate Solution (Akorn) – Low Viscosity (2018)

Failed Stability Specification: OOS low viscosity results discovered during retain testing.

FDAFeb 21, 2018Nationwide• Akorn, Inc.

Buttermilk Pancake Mix (Bob's Red Mill) – undeclared milk (2018)

Undeclared Milk

Buttermilk Pancake and Waffle Mix is recalled due to undeclared milk in the ingredients statement. The ingredients statement of Buckwheat Pancake and Waffle Whole Grain Mix and the nutritional label was mistakenly applied to packages of Buttermilk Pancake and Waffle Mix.

FDAFeb 20, 2018AZ, IN, NJ +2 more• Bob's Red Mill Natural Foods, Inc.

Organic Creamy Wheat Cereal (Bob's Red Mill) – undeclared wheat (2018)

Undeclared Gluten

Organic Creamy Wheat Hot Cereal is recalled due to undeclared wheat. The front label is correctly labeled as Organic Creamy Wheat Hot Cereal. However, the back label is mistakenly labeled as Outrageous Muffins which declares organic soy flour but wheat is not declared in the ingredients statement.

FDAFeb 16, 2018CA, FL, IL +3 more• Bob's Red Mill Natural Foods, Inc.

Monterey Jack Jalapeno Cheese (Springside) – pasteurization issue (2018)

Various cheeses are being recalled because they may have been made with milk that was held for 13.8 seconds during pasteurization.

FDAFeb 14, 2018AK, CO, FL +6 more• Springside Cheese Corp

Monterey Jack Chicken Soup Cheese (Springside) – pasteurization issue (2018)

Various cheeses are being recalled because they may have been made with milk that was held for 13.8 seconds during pasteurization.

FDAFeb 14, 2018AK, CO, FL +6 more• Springside Cheese Corp

Monterey Jack Chipotle Cheese (Springside) – pasteurization issue (2018)

Various cheeses are being recalled because they may have been made with milk that was held for 13.8 seconds during pasteurization.

FDAFeb 14, 2018AK, CO, FL +6 more• Springside Cheese Corp

Monterey Jack Onion & Chives Cheese (Springside) – pasteurization issue (2018)

Various cheeses are being recalled because they may have been made with milk that was held for 13.8 seconds during pasteurization.

FDAFeb 14, 2018AK, CO, FL +6 more• Springside Cheese Corp

Monterey Jack Garden Vegetable Cheese (Springside) – pasteurization issue (2018)

Various cheeses are being recalled because they may have been made with milk that was held for 13.8 seconds during pasteurization.

FDAFeb 14, 2018AK, CO, FL +6 more• Springside Cheese Corp

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