Reported Mar 15, 2017 · Terminated
Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) 120g tube (NDC 66993-877-78), Rx Only,…
Leo Pharma Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LEO PHARMA INC · 7 Giralda Farms · Madison, NJ · 07940-1051
Is this the product you have?
Calcipotriene Cream 0.0005%packaged in a) 60g tube(NDC 66993-877-61)b) 120g tube (NDC 66993-877-78)Rx Only
- Manufactured byLEO Pharma Inc., Dublin, Ireland
- Manufactured forPrasco Laboratories, Mason, OH, 45040
- Lot codes and dates
12 of 12 products
Products covered by this recall # Product as published 1 EK8760, Exp 2/17 2 EL1115, Exp 3/17 3 EL2358, Exp 4/17 4 EL6143, Exp 7/17 5 EM0837, Exp 10/17 6 EM2088, 12/17 7 A20899, Exp 5/18 8 A24492, Exp 6/18 9 EK8764, Exp 2/17 10 EL6145, Exp 7/17 11 EM2091, Exp 2/17 12 A25206, Exp 6/18. - Amount recalled
- 272,062 tubes
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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