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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

Theraflu 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, 2013

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AmBisome (Astellas Pharma) – sterility concern (2013)

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

Theraflu Exte (Novartis) – foreign substance risk (2013)

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

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

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

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

NeoCitran Extra Strength Cold & Flu (Novartis) – foreign substance risk (2013)

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

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

NeoCitran DM Cough & Cold (Novartis) – foreign substance risk (2013)

Theraflu Multi-Symptom Severe Cold (Novartis) – foreign substance risk (2013)

Theraflu Flu & Sore Throat (Novartis) – Foreign Substance Risk (2013)

Theraflu Sugar-Free Nighttime Severe Cold & Cough (Novartis) – foreign substance risk (2013)

Theraflu Flu & Chest Congestion (Novartis) – foreign substance risk (2013)

NeoCitran Extra Strength (Novartis) – foreign substance risk (2013)

NeoCitran Extra Strength Non-Drowsy Cold & Sinus (Novartis) – foreign substance risk (2013)

Theraflu (Novartis) – foreign substance risk (2013)

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

NeoCitran (Novartis) – foreign substance risk (2013)