Taclonex Topical Suspension Recalled for Outdated Package Insert
LEO Pharma Inc. is recalling Taclonex topical suspension because it was packaged with an out-of-date package insert.
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. The issue is a documentation/packaging error (outdated insert) rather than a product defect.
Plain-English summary
LEO Pharma Inc. is recalling Taclonex (calcipotriene and betamethasone dipropionate) Topical Suspension, 0.005%/0.064%. The affected product is packaged in 60 g and 120 g tubes and is a prescription-only medication. The recall involves 189,610 units distributed nationwide within the US.
The recall was initiated because the affected product was packaged with an out-of-date package insert (PI) dated February 2014. This is a labeling issue regarding the documentation provided with the medication.
Consumers and healthcare providers should check their inventory for the specific lot numbers listed in the recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for replacement or refund.
The recalled product
- Product
- TACLONEX (CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE)
- Brand
- TACLONEX
- Manufacturer
- LEO PHARMA INC
- Category
- Drug — Topical Prescription
- Hazard
- Affected units
- 189,610
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 (20)
- Lot #: (a): EK9025
- Exp. 2/28/2017
- EL1057
- Exp. 3/31/2017
- EL4637
- Exp. 6/30/2017
- EM0825B
- Exp. 11/30/2017
- EM3992
- Exp. 1/31/2019
- A22902
- Exp. 5/31/2019
- A31838
- Exp. 9/30/2019 Lot #:EK7007A
- EK7007AA
- Exp. 1/31/2017
- EL2024
- EL2979
- Exp. 5/31/2017
- EL8069
Distribution
Distributed nationwide across the United States.
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