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Label Mix-Up Prompts Acne Med Recall

June 27, 2019

Due to a label mix-up, Akorn Inc. is recalling 16,216 cartons of Myorisan (isotretinoin capsules), 40 mg, packaged in cartons of 30 capsules containing 3x10 prescription packs, distributed by VersaPharm Inc. (NDC 61748-304-13). According to the June 26, 2019, US Food and Drug Administration (FDA) Enforcement Report, the secondary carton erroneously states the strength as 40 mg instead of 30 mg. The primary carton is labelled correctly. 

Affected by the recall is Myorisan from lot V30M56A (Exp. 9/20), which was distributed throughout the United States. 

Akorn Inc. voluntarily initiated the recall June 7, 2019. On June 17, 2019, the FDA designated it Class III, suggesting use of the affected product is unlikely to cause adverse health consequences. 

Myorisan is a prescription retinoid used to treat severe acne. 

Jolynn Tumolo

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