July 20, 2018
Akorn Inc. is recalling more than 89,000 vials of acetylcysteine for injection, 6 g/30 mL (200 mg/mL) (NDC 17478-660-30), due to deviations from Current Good Manufacturing Practice regulations. According to the July 18, 2018, US Food and Drug Administration (FDA) Enforcement Report, Akorn initiated the recall June 22, 2018, at the request of the FDA.
The recall affects vials from lots 061496A (Exp. 6/18), 111696A (Exp. 11/18), 061947A (Exp. 6/19), and 091267A (Exp. 9/19). The affected vials were distributed across the United States.
On July 9, 2018, the FDA designated the recall Class II. A Class II designation signals use of the product could cause temporary or medically reversable harm. While a potential for serious harm also exists, the likelihood is remote.
Injection acetylcysteine is a prescription intravenous antidote for acetaminophen overdose.
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