FDA-Drug2020-01-08Class II
MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13.
Akorn, Inc.
Hazard
Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
Sold states
Nationwide in the USA and Puerto Rico
Affected count
4,206 boxes
Manufactured in
1925 W Field Ct Ste 300, N/A, Lake Forest, IL, United States
Products
MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0647-2020Don't want to check this manually?
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