Acetaminophen Overdose Antidote Cetylev Recalled

From Medscape:

Arbor Pharmaceuticals has recalled three lots of acetylcysteine (Cetylev) effervescent tablets for oral solution (500 mg) because of an inadequate seal of the blister pack, the US Food and Drug Administration (FDA) said today in a safety alert.

Cetylev effervescent tablets for oral solution are used as an antidote for acetaminophen overdose 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 FDA says that the problem with the seal of the blister pack on the recalled lots could lead to an increase of oxygen and moisture entering the blister cavity, which can start the effervescent process. This could result in enlarged and swelled tablets that could also completely dissolve within the blister pack.

The improper seal could also lead to a potentially subtherapeutic dose, which could lead to increased risk for liver injury.

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