The United States: Voluntary nationwide recall of Cetylev® (Acetylcysteine) Effervescent Tablets for Oral Solution due to an inadequate seal of the blister pack (English Only)

The United States: Voluntary nationwide recall of Cetylev® (Acetylcysteine) Effervescent Tablets for Oral Solution due to an inadequate seal of the blister pack (English Only)
 
Arbor Pharmaceuticals, LLC (Arbor) announced a voluntary recall of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg (Lot Numbers 005C16, 006C16 and 007C16, expiration date 02/2018), due to an inadequate seal of the blister pack. 

Cetylev (acetylcysteine) effervescent tablets for oral solution are indicated as an antidote for acetaminophen overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion. 

An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process, resulting in enlarged and swelled tablets which could completely dissolve within the blister pack. This may also result in partial dissolution of the tablets which can lead to a potentially sub-therapeutic dose and potential microbial contamination. Because the effectiveness of acetylcysteine to prevent or lessen hepatic injury after ingestion of acetaminophen is delayed with decreased therapy, sub-therapeutic dosing could lead to increased risk of liver injury. With regards to potential microbial contamination, the risk of serious infection is increased in certain patient populations such as children, pregnant women, immunosuppressed patients, and patients on gastric acid suppression therapy such as proton pump inhibitors. 

Healthcare facilities should immediately discontinue use from these lots of product and return all unused Cetylev to Arbor. To date, Arbor has not received any reports of adverse events related to this recall. Product was distributed nationwide to wholesalers and pharmacies. 

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm517264.htm 

In Hong Kong, the above product is not a registered pharmaceutical product. 


Ends/ Friday, August 19, 2016 
Issued at HKT 15:00 
 

 

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