LEO PHARMA INC: 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:

Is my product affected?

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

• Brand CALCIPOTRIENE

Check against the official notice below — it lists the full affected range.

What happened

LEO Pharma Inc. is recalling Calcipotriene Cream 0.0005% distributed nationwide in the United States. The recall affects approximately 272,062 tubes in two sizes: 60-gram tubes (NDC 66993-877-61) and 120-gram tubes (NDC 66993-877-78), manufactured by LEO Pharma Inc. in Dublin, Ireland. The affected lot numbers and expiration dates are specified for each tube size, ranging from February 2017 through June 2018.

The recall was issued because the Authorized Generic labeling inadvertently omitted a drug excipient and failed to include a contact dermatitis warning that appears on the brand product labeling. The source document does not specify a remedy for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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. Distribution: U.S. Nationwide Quantity: 272,062 tubes Lot/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.

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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