Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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.
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
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason Defective Delivery System: Potential defect that could prevent the product from dispensing as intended.
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Labeling: Incorrect or missing package insert: the affected product was packaged with an out-of-date package insert (PI) dated February 2014.
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
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