Cumberland Pharmaceuticals Inc. Announced a Recall of Acetadote

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On December 30, 2010, Cumberland Pharmaceuticals Inc. announced it had implemented a voluntary recall of 6 lots of Acetadote® (acetylcysteine) Injection.

Acetadote® is an injectable treatment for acetaminophen overdose. It is meant to be administered within 8 to 10 hours after ingestion to prevent or lessen the hepatic injury which occurs with a very large overdose of acetaminophen.

The voluntary recall by Cumberland of these lots of Acetadote is 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.

It is important to note this recall is not being undertaken on the basis of any known adverse medical events and affects a limited supply of the product.

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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 [email protected], by fax to 866-438-2372 or by phone at 1-877-484-2700.

Adverse reactions may also be reported to FDA's MedWatch Program online at www.fda.gov/medwatch, or by mail at MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787.

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