Thursday, August 18, 2016

Voluntary Nationwide Recall of Cetylev® (Acetylcysteine) Effervescent Tablets for Oral Solution Due to an Inadequate Seal of the Blister Pack

You are subscribed to Recalls, Market Withdrawals and Safety Alerts for U.S. Food & Drug Administration (FDA).

This information has recently been updated and is now available.

 

 

08/18/2016 12:58 PM EDT

Arbor Pharmaceuticals, LLC (Arbor) today announced a voluntary recall of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal of the blister pack. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process. This results in enlarged and swelled tablets which could also completely dissolve within the blister pack.

For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.


This email was sent to filter@clubhouseb.com using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 1-888-INFO-FDA (1-888-463-6332) Powered by GovDelivery

No comments:

Post a Comment