Antidote for Acetaminophen Overdose Recalled; Risk of Sub-Therapeutic Dosing

On August 18, 2016, Arbor Pharmaceuticals 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. 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 that could also completely dissolve within the blister pack.


Cetylev (acetylcysteine) effervescent tablets for oral solution are indicated as an antidote for acetaminophen overdose for prevention or lessening of hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated ingestion of quantities of acetaminophen in excess of the therapeutic dosage.


The improper seal of the product can lead to a potentially sub-therapeutic dose as well as potential microbial contamination. Because the effectiveness of acetylcysteine to prevent or lessen hepatic injury after ingestion of acetaminophen (Tylenol) is delayed with decreased therapy, sub-therapeutic dosing could lead to increased risk of liver injury. With regards to the potential microbial contamination due to moisture ingress into the tablets, 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.


Three lots of the 500 mg strength (Lot Numbers 005C16, 006C16, and 007C16, expiration date 02/2018) with NDC 24338-700-10 are included in the recall.


See the FDA Safety Alert


See the FDA Recall


See Medical Law Perspectives January 2014 Report: Prescription Painkillers: Risks for Patients, Pharmacists, and Physicians


See Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication