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Showing 9941–9960 of 14370 results

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

Subpotent drug

Class IIILow

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

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

Subpotent drug

Class IIILow

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

Glucosamine MSM Capsules (Natural Creations) – undeclared shellfish (2015)

Natural Creations is recalling Glucosamine MSM dietary supplement due to unlabeled allergen (shellfish).

Class IIModerate

FDAMay 4, 2015Nationwide• Natural Creations Inc

MaxiFlex Multinutrient Formula (MedOp Health) – material review (2015)

Maxivision MaxiFlex (Registered) Multinutrient Formula, 120 Vegetable Capsules is being recalled because a material review was conducted in April 2015. It revealed some of the Chondroitin Sulfate (Lot 093011 1031) raw material used in the manufacture of Maxiflex Multinutrient Formula Lot 32171215 was Out of Specification.

Class IIILow

FDAApr 30, 2015AL, AZ, CA +19 more• MedOp Health, Inc.

Sulfacetamide Sulfur Sunscreen Wash (Mission) – Microbial Contamination (2015)

Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.

Class IIModerate

FDAApr 30, 2015Nationwide• Mission Pharmacal Co

Sodium Sulfacetamide Sulfur Wash Kit (Mission) – Microbial Contamination (2015)

Microbial Contamination of Non-Sterile Products: Product failed USP Microbial Limits Test.

Class IIModerate

FDAApr 30, 2015Nationwide• Mission Pharmacal Co

Azithromycin 500mg Tablets (PD-Rx) – CGMP Manufacturing Issue (2015)

cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 29, 2015Nationwide• PD-Rx Pharmaceuticals, Inc.

Ortho-Cept Birth Control (Janssen) – Subpotent Medication (2015)

Subpotent Drug

Class IIModerate

FDAApr 29, 2015Nationwide• Janssen Pharmaceuticals, Inc.

Azithromycin 250mg Tablets (PD-Rx) – CGMP Manufacturing Issue (2015)

cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 29, 2015Nationwide• PD-Rx Pharmaceuticals, Inc.

Kabiven Injectable Emulsion (Fresenius) – Labeling Strength Error (2015)

Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids

Class IIModerate

FDAApr 28, 2015Nationwide• Fresenius Kabi USA, LLC

Adrucil Injection (Teva) – Particulate Matter Contamination (2015)

Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.

Class IHigh

FDAApr 28, 2015Nationwide• Teva Pharmaceuticals USA

Phenylephrine Sodium Chloride (SCA) – Labeling Mix-Up (2015)

Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.

Class IIModerate

FDAApr 28, 2015CA• SCA Pharmaceuticals

Levalbuterol Inhalation Solution (Cipla) – Impurity Specification Failure (2015)

Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.

Class IIILow

FDAApr 24, 2015Nationwide• Cipla Limited

Alinia Oral Suspension (Romark) – Stability Specification Failure (2015)

Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity

Class IIModerate

FDAApr 24, 2015Nationwide• Romark Laboratories, L.C.