FDA-Drug2019-06-26Class III
Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13
Akorn Inc
Hazard
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Sold states
Nationwide USA
Affected count
16,216 cartons
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsules containing 3 x 10 Prescription Packs, Rx Only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forest, IL 60045, NDC 61748-304-13
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1392-2019Don't want to check this manually?
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