Cetylev Tablets Recalled

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Arbor Pharmaceuticals is voluntarily recalling Cetylev (acetylcysteine) effervescent tablets due to inadequate seal of the blister pack.

On August 18, 2016, Arbor Pharmaceuticals announced a voluntary recall of three lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg. The recall is a result of an inadequate seal of the blister pack, which could result in a release of oxygen and moisture potentially causing the tablets to enlarge and dissolve in the blister pack. The company has not yet received any reports of adverse events.

Cetylev (acetylcysteine) effervescent tablets for oral solution are used as an antidote for acetaminophen overdose. The tablets may prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen in patients with acute ingestion or from repeated supratherapeutic ingestion. According to Arbor, an inadequate product seal that leads to excess moisture and partial dissolution of the tablets may cause 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 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,” the company stated in a press release.

The recalled lots are 500 mg strength (Lot Numbers 005C16, 006C16, and 007C16, expiration date 02/2018) with NDC 24338-700-10 and were distributed nationwide to wholesalers and pharmacies. The company is advising all healthcare facilities to discontinue use of the affected lots. Adverse events may be reported to FDA.


Source: FDA