Recall Enforment Report D-0510-2017

Drug Recall Enforcement Report Class II voluntary initiated by LEO PHARMA INC, originally initiated on 01-19-2017 for the product Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040 The product was recalled due to incorrect/undeclared excipients: inadvertent omission of a drug excipient from the the authorized generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the authorized generic labeling.. The product was distributed nationwide and the recall is currently terminated.

Field Name	Field Value
Event ID	76467 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0510-2017 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	U.S. Nationwide What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only, Manufactured by: LEO Pharma Inc., Dublin, Ireland, Manufactured for: Prasco Laboratories, Mason, OH, 45040
Reason For Recall	Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized Generic label and also a warning regarding contact dermatitis from the brand product labeling not being incorporated into the Authorized Generic labeling. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	272,062 tubes Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	03-15-2017
Recall Initiation Date	01-19-2017 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	01-24-2018 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Letter Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	LEO PHARMA INC
Code Info	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, Exp 2/17; EL6145, Exp 7/17; EM2091, Exp 2/17; A25206, Exp 6/18. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	66993-877-61; 66993-877-78
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products