Audience: Pharmacy, Patient [Posted 02/07/2011]

ISSUE: An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg,…

Audience: Pharmacy, Patient [Posted 02/07/2011]

ISSUE: An individual bottle of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg / 500mg, NDC 0603-3888-20, 60 count was found incorrectly labeled with a Phenobarbital Tablets, USP 32.4 mg,…

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Audience: Endocrinology, Cardiology [UPDATED 02/04/2011] FDA notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of rosiglitazone has been added to the physician labeling and patient…

Audience: Endocrinology, Cardiology [UPDATED 02/04/2011] FDA notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of rosiglitazone has been added to the physician labeling and patient…

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Audience: Pharmacy, Consumer, Risk Manager [UPDATED 01/28/2011] Triad Alcohol Prep Pads may have been included in U.S. packaging for Arixtra Starter Kits manufactured by GlaxoSmithKline (GSK). The Triad alcohol prep pads should not be…

Audience: Pharmacy, Consumer, Risk Manager [UPDATED 01/28/2011] Triad Alcohol Prep Pads may have been included in U.S. packaging for Arixtra Starter Kits manufactured by GlaxoSmithKline (GSK). The Triad alcohol prep pads should not be…

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[UPDATED 01/27/2011] Additional information about the model and lot numbers affected has been included in an updated Class I Recall Notice.
 
[Posted 12/29/2010]
AUDIENCE: Risk Manager, Surgery
ISSUE: The Arrow Ultra 8 Intra-Aortic Balloon…

[UPDATED 01/27/2011] Additional information about the model and lot numbers affected has been included in an updated Class I Recall Notice.
 
[Posted 12/29/2010]
AUDIENCE: Risk Manager, Surgery
ISSUE: The Arrow Ultra 8 Intra-Aortic Balloon…

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[UPDATED 01/26/2011] Triad Alcohol Prep Pads are packaged for use with the kit presentation of Relistor (methylnaltrexone bromide) Subcutaneous Injection in the U.S. The Relistor vial and other components of the kit are not affected by the…

 
[UPDATED 01/26/2011] Triad Alcohol Prep Pads are packaged for use with the kit presentation of Relistor (methylnaltrexone bromide) Subcutaneous Injection in the U.S. The Relistor vial and other components of the kit are not affected by the…

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[Posted 1/26/2011]
AUDIENCE:  Plastic Surgery, Oncology, Hematology
ISSUE: FDA announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data…

[Posted 1/26/2011]
AUDIENCE:  Plastic Surgery, Oncology, Hematology
ISSUE: FDA announced a possible association between saline and silicone gel-filled breast implants and anaplastic large cell lymphoma (ALCL), a very rare type of cancer. Data…

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Audience: Pharmacy, Consumer, Risk Manager [UPDATED 01/21/2011] Triad alcohol prep pads packaged for use in the U.S. with Betaseron (interferon beta 1-b) should not be used by patients. There is no involvement or potential contamination of the…

Audience: Pharmacy, Consumer, Risk Manager [UPDATED 01/21/2011] Triad alcohol prep pads packaged for use in the U.S. with Betaseron (interferon beta 1-b) should not be used by patients. There is no involvement or potential contamination of the…

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[UPDATED 01/14/2011]
The Triad Group alcohol prep pads are co-packaged and distributed with Genentech medicines Boniva Injection, Fuzeon, Nutropin A.Q.Pen, Pegasys, and TNKase to customers in the United States. Genentech medicines are not…

[UPDATED 01/14/2011]
The Triad Group alcohol prep pads are co-packaged and distributed with Genentech medicines Boniva Injection, Fuzeon, Nutropin A.Q.Pen, Pegasys, and TNKase to customers in the United States. Genentech medicines are not…

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Audience: Cardiology, Gastroenterology ISSUE: FDA notified healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart…

Audience: Cardiology, Gastroenterology ISSUE: FDA notified healthcare professionals and patients about cases of rare, but severe liver injury, including two cases of acute liver failure leading to liver transplant in patients treated with the heart…

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Audience: Pharmacy, Oncology, Pain Management ISSUE: Roxane Laboratories and FDA notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially when using the…

Audience: Pharmacy, Oncology, Pain Management ISSUE: Roxane Laboratories and FDA notified healthcare professionals of serious adverse events and deaths resulting from accidental overdose of morphine sulfate oral solutions, especially when using the…

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