Recalls / Class II
Class IID-0510-2017
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
- Brand name
- Calcipotriene
- Generic name
- Calcipotriene
- Active ingredient
- Calcipotriene
- Route
- Topical
- NDC
- 66993-877
- FDA application
- NDA020554
- Affected 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.
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.
Recalling firm
- Firm
- LEO PHARMA INC
- Manufacturer
- Prasco Laboratories
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7 Giralda Farms, N/A, Madison, New Jersey 07940-1051
Distribution
- Quantity
- 272,062 tubes
- Distribution pattern
- U.S. Nationwide
Timeline
- Recall initiated
- 2017-01-19
- FDA classified
- 2017-03-03
- Posted by FDA
- 2017-03-15
- Terminated
- 2018-01-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0510-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.