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Monthly Archives:
August 2014

27

August
2014

category:

503b Compounding

Who can Recall what FDA’s Mandatory Recall Authority is? A U.S. District Court Could Not…

It is rare that we urge our readers to keep a copy of a court ruling or brief.  A Brief that FDA filed on August 21, 2014 is an exception.  Companies and others should read this brief and keep it close at hand. When someone wants to question FDA’s legal authority to compel a recall, this brief […]

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27

August
2014

category:

503b Compounding

Recall of Allerex and Optodexine Eye Drops

Hong Kong (HKSAR) – The Department of Health (DH) today (August 27) endorsed a licensed drug wholesaler, Ashford Pharmaceuticals Limited, to recall from the market all batches of Allerex Eye Drops (registration number: HK-54384) and Optodexine Eye Drops (registration number: HK-54304) due to a potential quality issue.The DH received notification from the manufacturer of both […]

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27

August
2014

category:

503b Compounding

Contaminated Antibiotic Recalled

Federal health officials are alerting doctors to the recall of an injectable antibiotic made by B. Braun Medical, due to floating particles found in vials of the drug.The Food and Drug Administration posted the notice late Tuesday, warning health professionals that the company has recalled lot H3A7444 of its Cefepime for Injection USP and Dextrose […]

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