LEO Pharma Recalls Calcipotriene Cream Due to Labeling Errors
LEO Pharma is recalling 272,062 tubes of Calcipotriene Cream because the label omitted a required excipient and a warning about contact dermatitis.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to labeling errors (omitted excipient and warning), which fits the rubric for minor labeling errors and low-risk contamination without reported injuries.
Plain-English summary
LEO Pharma Inc. is recalling 272,062 tubes of Calcipotriene Cream 0.0005% (NDC 66993-877-61 and 66993-877-78) distributed nationwide in the United States. The recall was initiated because the product labeling for the Authorized Generic version inadvertently omitted a drug excipient and failed to include a warning regarding contact dermatitis that is present in the brand product labeling.
The affected lots include EK8760, EL1115, EL2358, EL6143, EM0837, EM2088, A20899, A24492, EK8764, EL6145, EM2091, and A25206. These products were manufactured by LEO Pharma Inc. in Dublin, Ireland, and manufactured for Prasco Laboratories in Mason, Ohio. The recall is classified as FDA Class II, indicating a situation that might cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients currently using the medication should consult their healthcare provider for guidance on continuing treatment or switching to an alternative product.
The recalled product
- Product
- CALCIPOTRIENE (CALCIPOTRIENE)
- Brand
- CALCIPOTRIENE
- Manufacturer
- LEO PHARMA INC
- Category
- Drug — Topical Prescription
- Affected units
- 272,062
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) EK8760
- Exp 2/17
- EL1115
- Exp 3/17
- EL2358
- Exp 4/17
- EL6143
- Exp 7/17
- EM0837
- Exp 10/17
- EM2088
- 12/17
- A20899
- Exp 5/18
- A24492
- Exp 6/18
- b) EK8764
- EL6145
- EM2091
- A25206
Distribution
Distributed nationwide across the United States.
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