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Showing 12981–13000 of 14370 results

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Gastrografin (Bracco Diagnostics) – Foreign Substance Risk (2013)

Presence of foreign substance: One lot of the product may contain black foreign particles

Class IIModerate

FDAJun 21, 2013Nationwide• Bracco Diagnostics Inc

Phentalene Capsules (Beta Labs) – prohibited supplement (2013)

The products contain DMAA, also known as 1,3-dimethylamylamine, methylhexamine or geranium extract, which is not permitted in dietary supplements.

FDAJun 20, 2013Nationwide• Beta Labs

Red Vipers (Beta Labs) – prohibited supplement (2013)

The products contain DMAA, also known as 1,3-dimethylamylamine, methylhexamine or geranium extract, which is not permitted in dietary supplements.

Class IIModerate

FDAJun 20, 2013Nationwide• Beta Labs

PHEnFX Capsules (Beta Labs) – prohibited supplement (2013)

The products contain DMAA, also known as 1,3-dimethylamylamine, methylhexamine or geranium extract, which is not permitted in dietary supplements.

Class IIModerate

FDAJun 20, 2013Nationwide• Beta Labs

AmBisome (Gilead Sciences) – sterility concern (2013)

Lack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.

Class IIModerate

FDAJun 20, 2013Nationwide• Gilead Sciences, Inc.

Oxyphen XR (Beta Labs) – prohibited supplement (2013)

The products contain DMAA, also known as 1,3-dimethylamylamine, methylhexamine or geranium extract, which is not permitted in dietary supplements.

Class IIModerate

FDAJun 20, 2013Nationwide• Beta Labs

AmBisome (Astellas Pharma) – sterility concern (2013)

Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.

Class IIModerate

FDAJun 19, 2013Nationwide• Astellas Pharma US Inc

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.

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.

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.

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

NeoCitran Extra Strength 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

Theraflu Flu & Chest Congestion (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 Multi-Symptom Severe Cold (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 Flu & Sore Throat (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

NeoCitran (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 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

Theraflu Sugar-Free Nighttime 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

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 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

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