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Showing 11781–11800 of 14370 results

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Ketoconazole Cream (Fougera) – Degradation Specs (2013)

Failed Impurities/Degradation Specifications: Out-of-Specification degradant results.

FDANov 18, 2013Nationwide• Fougera Pharmaceuticals Inc.

RezzRX Capsules (Fossil Fuel) – Undeclared Ingredients (2013)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: Fossil Fuel Products, is recalling RezzRX due to undeclared hydroxylthiohomosildenafil and aminotadalafil.

FDANov 18, 2013Nationwide

• Fossil Fuel Products, LLC

MaXtremeZEN Capsules (SS Wholesale) – Undeclared API (2013)

Undeclared Allergen

Marketed Without An Approved NDA/ANDA: FDA analysis found MaXtremeZEN which is marketed as a dietary supplement to contain undeclared desmethyl carbondenafil and dapoxetine. Desmethyl carbondenafil is a phosphodiesterase (PDE)-5 inhibitors which is a class of drugs used to treat male erectile dysfunction, making this product an unapproved new drug. Dapoxetine is an active ingredient not approved

FDANov 18, 2013CA• SS Wholesale Inc. dba Jobbers Wholesale

Phenylephrine Nasal Spray (Tower Pharmacy) – Microbial Contamination (2013)

Microbial Contamination of Non Sterile Products: Tower Pharmacy is recalling the Phenylephrine Nasal Spray 1% because of possible microbial contamination.

Class IIModerate

FDANov 16, 2013CA• Tower Pharmacy and Compounding

Enzym-Complete/DPP-IV (Kirkman) – Contamination Risk (2013)

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol

Class IIModerate

FDANov 15, 2013Nationwide• Kirkman Group Inc.

EnZym-Complete/DPP-IV II (Kirkman) – Contamination Risk (2013)

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol

Class IIModerate

FDANov 15, 2013Nationwide• Kirkman Group Inc.

Chewable EnZym-Complete (Kirkman) – Contamination Risk (2013)

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol

Class IIModerate

FDANov 15, 2013Nationwide• Kirkman Group Inc.

Maximum Spectrum EnZym-Complete (Kirkman) – Contamination Risk (2013)

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol

Class IIModerate

FDANov 15, 2013Nationwide• Kirkman Group Inc.

Bupropion XL Tablets (Actavis) – Dissolution Failure (2013)

Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.

FDANov 15, 2013Nationwide• Actavis Inc

Alphamine (Physique) – Unapproved Ingredient (2013)

Products contain "Aegeline" an unapproved New Dietary Ingredient.

Class IIModerate

FDANov 15, 2013Nationwide• Physique Enhancing Science

Maximum Spectrum Enzym (Kirkman) – chemical contamination (2013)

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol

Class IIModerate

FDANov 15, 2013Nationwide• Kirkman Group Inc.

Biofilm Defense (Kirkman) – Contamination Risk (2013)

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol

Class IIModerate

FDANov 15, 2013Nationwide• Kirkman Group Inc.

Phenol Assist (Kirkman) – Chloramphenicol Contamination (2013)

Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol

Class IIModerate

FDANov 15, 2013Nationwide• Kirkman Group Inc.

Enhanced Pre-Workout (Physique) – Unapproved Ingredient (2013)

Products contain "Aegeline" an unapproved New Dietary Ingredient.

Class IIModerate

FDANov 15, 2013Nationwide• Physique Enhancing Science

Digestive Enzymes (4Life Research) – antibiotic contamination (2013)

4Life Research, LLC is voluntarily recalling various lots of Digestive Enzymes product due to the presence of trace amounts of the antibiotic, chloramphenicol.

Class IIModerate

FDANov 14, 2013IN, VA• 4Life Research, LLC

Fluconazole Suspension (Teva) – Preservative Issue (2013)

Failed Stability Specifications: this product is below specification for preservative content.

FDANov 14, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Gluten Free Capsules (MRM) – antibiotic contamination (2013)

Metabolic Response Modifier (MRM) is recalling Gluten Free 60 vcaps because it may contain trace amounts of the antibiotic, chloramphenicol.

Class IIModerate

FDANov 13, 2013Nationwide• Mrm

Namenda XR (Forest) – Dissolution Failure (2013)

Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.

FDANov 13, 2013Nationwide• Forest Pharmaceuticals Inc

Glycopyrrolate Injectable (Brookfield) – Non-Sterile (2013)

Non-Sterility: One lot of Glycopyrrolate solution for injection was found to be contaminated with Bacillus thuringiensis.

FDANov 13, 2013WI• Brookfield Prescription Center Inc

Namenda XR (Forest) – Dissolution Failure (2013)

Failed Dissolution Specifications: Three lots of product being recalled having failed stability dissolution testing.

FDANov 13, 2013Nationwide• Forest Pharmaceuticals Inc

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