Cetylev Lots Recalled Due to Package Seal Problem

Arbor Pharmaceuticals is recalling 3 lots of acetylcysteine (Cetylev) effervescent tablets for oral solution (500 mg) because their blister packs may have inadequate seals.

This issue could allow more oxygen and moisture to enter the packaging and initiate the products’ effervescent process, which could result in enlarged, swelled tablets that completely dissolve within the blister packs. Improper seal of the product could also potentially lead to subtherapeutic dosing and microbial contamination because of moisture ingress into the tablets.

The 3 lots included in the recall are 005C16, 006C16, 007C16. Each is marked with NDC 24338-700-10 and has an expiration date of February 2018.

Cetylev is indicated as an antidote for acetaminophen overdose to prevent or lessen hepatic injury after the ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion. Because the drug’s effectiveness for this indication is delayed with decreased therapy, those who receive a subtherapeutic dose of Cetylev could be at increased risk for liver injury. In addition, the use of Cetylev with microbial contamination increases the risk of serious infection in certain patient populations, such as children, pregnant women, immunosuppressed patients, and those on gastric acid suppression therapy.

As of August 18, 2016, Arbor has not received any reports of adverse events related to the recalled products. Nevertheless, health care facilities should immediately discontinue use of the affected lots and return all unused Cetylev to Arbor. Health care professionals and patients are also encouraged to report adverse events related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program.