Akorn Recalls Myorisan Isotretinoin Capsules Due to Labeling Error
Akorn Inc. is recalling 16,216 cartons of Myorisan isotretinoin capsules because secondary cartons incorrectly state 40 mg instead of 30 mg.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a minor labeling error on the secondary packaging.
Plain-English summary
Akorn Inc. is recalling 16,216 cartons of Myorisan (isotretinoin capsules, USP), 40 mg, NDC 61748-304-13. The recall is due to a labeling error where the secondary carton erroneously states 40 mg instead of 30 mg, although the primary carton is labeled correctly.
The affected product is distributed nationwide in the United States. The specific lot number is V30M56A with an expiration date of 9/20.
Consumers should check their medication packaging for the incorrect secondary carton label. If the product matches the description, they should contact their pharmacist or healthcare provider for guidance on the appropriate action.
The recalled product
- Product
- 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
- Manufacturer
- Akorn Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 16,216
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: V30M56A
- Exp 9/20
Distribution
Distributed nationwide across the United States.
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