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Showing 2541–2560 of 3363 results

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Spring Water (Acadia) – E. Coli Contamination (2015)

Source Spring Water was analyzed and found positive for E. coli and total coliform

FDAJun 19, 2015CT, FL, ME +11 more• Niagara Bottling, LLC

Mandarin Oranges (Sysco) – Chemical Contamination (2015)

Product tested positive for Carbendazim.

FDAJun 18, 2015AL, FL, GA +5 more• Sysco Corporation

Disulfiram Tablets (Qualitest) – Failed Dissolution Test (2015)

Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.

Class IIILow

FDAJun 18, 2015Nationwide• Qualitest Pharmaceuticals

Diet Bubba Cola (Dr. Pepper Snapple) – Undeclared Ingredients (2015)

The firm was notified by one of it's retail stores that the ingredient statement does not declare citric acid, potassium benzoate, aspartame, and acesulfame potassium. The product contains the label for a regular drink instead of a diet drink.

FDAJun 10, 2015CA, CO, FL +13 more• Dr. Pepper Snapple Group Inc

Lime Electrolyte Water (Refreshe) – Coliform Contamination (2015)

Lime Flavored Electrolyte bottled Water is recalled due to high total coliform testing results.

FDAJun 10, 2015AZ, CA, CO +7 more• The Sweetwater Co., Inc.

Mixed Berry Electrolyte Water (HyVee) – Coliform Contamination (2015)

Mixed Berry Flavored Electrolyte Water is recalled due to high total coliform testing results.

FDAJun 10, 2015AZ, CA, CO +7 more• The Sweetwater Co., Inc.

Lemon Electrolyte Water (HyVee) – Coliform Contamination (2015)

Lemon Flavored Electrolyte water is recalled due to high total coliform testing results.

FDAJun 10, 2015AZ, CA, CO +7 more• The Sweetwater Co., Inc.

Carb-O-Philic 40 Cream (Geritrex) - CGMP Deviation (2015)

CGMP Deviation: Poor container closure of the bulk storage container

FDAJun 5, 2015Nationwide• Geritrex Corp

Dr Blue Pain Relieving Gel (Indiana Botanic Gardens) - Superpotent Drug (2015)

Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.

FDAJun 4, 2015Nationwide• Indiana Botanic Gardens, Inc

Lutera (Actavis) – Incorrect Package Insert (2015)

Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.

FDAJun 4, 2015Nationwide• Actavis Inc

E-Z-CAT Dry (Bracco Diagnostic) – viscosity specification (2015)

Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.

FDAMay 27, 2015Nationwide• Bracco Diagnostic Inc

Foradil Aerolizer (Novartis) – Stability Specification Failure (2015)

Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.

FDAMay 22, 2015NJ• Novartis Pharmaceuticals Corp.

Foradil Aerolizer (Novartis) – Stability Specification Failure (2015)

Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.

FDAMay 22, 2015NJ• Novartis Pharmaceuticals Corp.

Magnesium Sulfate Injection (Hospira) – pH Specification Failure (2015)

Failed pH Specifications: 12 month stability testing

FDAMay 19, 2015Nationwide• Hospira Inc.

Fresh Strawberries (Driscoll) – Pesticide Excess (2015)

Firm initiated a recall of certain codes dates of strawberries due to detection of the pesticide Naled at a level over the EPA tolerance of 1.0 ppm.

FDAMay 19, 2015Nationwide• Driscoll Watsonville

Fentanyl Citrate Injection (West-Ward) – Impurity Specification Failure (2015)

Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).

FDAMay 13, 2015Nationwide• West-Ward Pharmaceutical Corp.

QVAR Inhalation Aerosol (Teva) – Impurity Specification Failure (2015)

Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.

FDAMay 7, 2015Nationwide• Teva Pharmaceuticals USA

Amlodipine Atorvastatin 10/40mg (Dr. Reddy's) – Subpotent Medication (2015)

Subpotent drug

FDAMay 6, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Amlodipine Atorvastatin 10/10mg (Dr. Reddy's) – Subpotent Medication (2015)

Subpotent drug

FDAMay 6, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

Amlodipine Atorvastatin 5/10mg (Dr. Reddy's) – Subpotent Medication (2015)

Subpotent drug

FDAMay 6, 2015Nationwide• Dr. Reddy's Laboratories, Inc.

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