Arbor announced a Class II drug recall of three lots of Cetylev (acetylcysteine) effervescent tablets for oral solution due to possible degradation of the effervescent tablets.
Cetylev was approved by the Food and Drug Administration in February 2016 and is indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen (APAP) in patients with acute ingestion or from repeated supratherapeutic ingestion (RSI). Acetylcysteine is presumed to protect the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolites of acetaminophen.
The recall was initiated following an incomplete seal on the blister packaging. The affected lots of Cetylev 500mg were shipped between May 24, 2016 and July 18, 2016:
- Lot #005C16, Exp date 2/2018
- Lot #006C16, Exp date 2/2018
- Lot #007C16, Exp date 2/2018
The recalled Cetylev products are supplied in 2-count peelable foil blister packs as 10-count cartons containing 20 tablets each. The effervescent tablets are intended to be mixed with water, resulting in a lemon-mint flavored solution. Anyone in possession of the recalled products should quarantine them and return to the wholesaler.
For more information call (866) 516-4950 or visit arborpharma.com.