Arbor Pharmaceuticals Issues Recall of Cetylev Effervescent Tablets Due to an Inadequate Seal of the Blister Pack

This could result in enlarged tablets that could completely dissolve within the blister pack

Arbor Pharmaceuticals Issues Recall of Cetylev Effervescent Tablets Due to an Inadequate Seal of the Blister Pack
Image: NCCC
August 23, 2016

Arbor Pharmaceuticals has announced a voluntary recall of three lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal of the blister pack.

Cetylev 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.

The recalled product was distributed nationwide to wholesalers and pharmacies.

The impacted lots of the 500 mg strength Cetylev tablets are lot numbers 005C16, 006C16 and 007C16, with the expiration date 02/2018 and identifying code NDC 24338-700-10.

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 and can lead to a potentially sub-therapeutic dose as well as potential microbial contamination.

Due to the 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 of the affected lots and return all unused Cetylev to Arbor.

To date, Arbor has not received any reports of adverse events related to this recall.

For further information regarding this recall, contact Arbor Pharmaceuticals at (866) 516-4950.

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