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
Reported: June 26, 2019 Initiated: June 7, 2019 #D-1392-2019
Product Description
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
Reason for Recall
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Details
- Recalling Firm
- Akorn Inc
- Units Affected
- 16,216 cartons
- Distribution
- Nationwide USA
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Akorn Inc. Units affected: 16,216 cartons.
Why was this product recalled? ▼
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 26, 2019. Severity: Low. Recall number: D-1392-2019.
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