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Showing 13001–13020 of 14370 results

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Theraflu Cold and Flu (Novartis) – foreign substance risk (2013)

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Class IIModerate

FDAJun 18, 2013Nationwide• Novartis Consumer Health

Theraflu MAX-D Severe Cold & Flu (Novartis) – foreign substance risk (2013)

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Class IIModerate

FDAJun 18, 2013Nationwide• Novartis Consumer Health

Amoxicillin Oral Suspension (Teva) – Orange Discoloration (2013)

Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.

Class IIILow

FDAJun 18, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Theraflu Daytime Severe Cold & Cough (Novartis) – foreign substance risk (2013)

Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.

Class IIModerate

FDAJun 18, 2013Nationwide• Novartis Consumer Health

Methylphenidate Extended-Release (Teva) – dissolution failure (2013)

Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.

Class IIModerate

FDAJun 18, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Enteric Coated Aspirin (Advance Pharmaceutical) – Label Mix-Up (2013)

Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.

FDAJun 17, 2013Nationwide• Advance Pharmaceutical Inc

Belladonna Alkaloids/PB (Physicians Total Care) – Black Spots (2013)

Presence of Foriegn Substance:The manufacturer, West-ward Pharmaceutical, recalled product because of the presence of black spots on tablets. In response, the repackager initiated its own recall.

Class IIModerate

FDAJun 17, 2013GA• Physicians Total Care, Inc.

Medroxyprogesterone Acetate (Bayer) – Stability Failure (2013)

Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.

FDAJun 13, 2013CA, NY• Bayer HealthCare Pharmaceuticals Inc.

ChloraPrep With Tint (CareFusion) – Unsealed Pouches (2013)

Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.

Class IIModerate

FDAJun 13, 2013Nationwide• CareFusion 213, LLC

Bethel 30 Capsules (Bethel Nutritional) – Undeclared Ingredients (2013)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA analysis found this product contained undeclared sibutramine and phenolphthalein, two active ingredients that were once marketed in the U.S. but removed due to safety reasons, making this product an unapproved new drug.

FDAJun 11, 2013Nationwide• Bethel Nutritional Consulting, Inc

Liver Strong Capsules (Healthmaxx) – Mislabeling Concerns (2013)

In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.

FDAJun 10, 2013CA, MD, NY• Healthmaxx Global Inc.

Bio-Cell Collagen II (Healthmaxx) – Mislabeling Concerns (2013)

In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.

Class IIModerate

FDAJun 10, 2013CA, MD, NY• Healthmaxx Global Inc.

Organic OPC69 Capsules (Healthmaxx) – Mislabeling Concerns (2013)

In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.

FDAJun 10, 2013CA, MD, NY• Healthmaxx Global Inc.

CoQ10 Capsules (Healthmaxx Global) – Mislabeling (2013)

In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.

FDAJun 10, 2013CA, MD, NY• Healthmaxx Global Inc.

LiveAid Supplement (Healthmaxx Global) – Mislabeling (2013)

In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.

FDAJun 10, 2013CA, MD, NY• Healthmaxx Global Inc.

Brazilian Bee Propolis Softgels (Healthmaxx Global) – Mislabeling (2013)

In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.

FDAJun 10, 2013CA, MD, NY• Healthmaxx Global Inc.

Blood Sugar Defense Tablets (Healthmaxx Global) – Mislabeling (2013)

In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.

FDAJun 10, 2013CA, MD, NY• Healthmaxx Global Inc.

Super Selenium Tablets (Healthmaxx Global) – Mislabeling (2013)

In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.

FDAJun 10, 2013CA, MD, NY• Healthmaxx Global Inc.

CoQ-10 Capsules (Healthmaxx Global) – Mislabeling (2013)

In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.

FDAJun 10, 2013CA, MD, NY• Healthmaxx Global Inc.

Kidney Strong Tablets (Healthmaxx Global) – Mislabeling (2013)

In response to a FDA inspection, the firm initiated this voluntary recall of various dietary supplements due to the following problems of mislabeling: 1) product named on the label is not actual product contained; 2)ingredients listed are not actual ingredients contained.

FDAJun 10, 2013CA, MD, NY• Healthmaxx Global Inc.

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