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.
The FDA says there is also a risk for potential microbial contamination because of moisture ingress into the tablets. The risk for 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.
The recall includes lot numbers 005C16, 006C16, and 007C16, with expiration date 02/2018 and with National Drug Code (NDC) 24338-700-10.
Healthcare facilities are advised to immediately discontinue using product from the recalled lots and return all unused Cetylev to Arbor. Consumers with questions regarding this recall should contact Arbor Pharmaceuticals at 1-866-516-4950, Monday through Friday, between 9:00 AM and 5:00 PM, Eastern Time (ET).
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
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Cite this: Acetaminophen Overdose Antidote Cetylev Recalled - Medscape - Aug 18, 2016.
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