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Cumberland Pharmaceuticals Announces Voluntary Recall of Acetadote® Vials
Date:12/30/2010

NASHVILLE, Tenn., Dec. 30, 2010 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX) announced today that it has implemented a recall of 6 lots of Acetadote® (acetylcysteine) Injection, the Company's injectable treatment to prevent or lessen liver injury after ingestion of a potentially toxic quantity of acetaminophen. Cumberland informed the U.S. Food and Drug Administration (FDA) of its plans to voluntarily recall these lots of Acetadote as a precautionary measure based on observed particulate matter found in a very small number of vials. The source of the particulate matter was from the glass vial produced by a former supplier. The recall, which is not being undertaken on the basis of any known adverse medical events, affects a limited supply of product.

"We are recalling certain lots manufactured by a previous packaging supplier as a precautionary measure, and believe the risk of any serious adverse medical events to be remote," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "As part of ongoing quality assessment, we switched to a new vial packaging supplier in August of 2009. Patient safety, as always, remains our highest priority, and we are committed to taking the necessary steps to proactively protect patients from the potential of any safety risks."

The product being recalled is Acetadote (acetylcysteine) Injection, 20% solution (200mg/mL) in 30 mL single dose glass vials, NDC 66220-107-30. The lot numbers being recalled are lots 090304 (expiration Feb 2011), 090331 (expiration Feb 2011), 090401 (expiration Mar 2011), 090511 (expiration Apr 2011), 090602 (expiration May 2011) and 090616 (expiration May 2011). This product was distributed to U.S. wholesalers and distributors nationwide.

To report adverse reactions or quality concerns, please contact Cumberland Pharmaceuticals via email at

SOURCE Cumberland Pharmaceuticals Inc.
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