Reported Jan 8, 2020 · Terminated

MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx…

Akorn, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Akorn, Inc. · 1925 W Field Ct Ste 300 · Lake Forest, IL · 60045-4862

Is this the product you have?

  • MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only
  • Distributed byVersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13
Lot codes and dates
    • Lot V20M54A
    • Exp 01/2021
Amount recalled
4,206 boxes

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Aug 9, 2022 · Data as of Sep 19, 7:23 PM UTC

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