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
Reported: March 15, 2017 Initiated: January 19, 2017 #D-0510-2017
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.
Details
- Recalling Firm
- LEO PHARMA INC
- Units Affected
- 272,062 tubes
- Distribution
- U.S. Nationwide
- Location
- Madison, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by LEO PHARMA INC. Units affected: 272,062 tubes.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 15, 2017. Severity: Moderate. Recall number: D-0510-2017.
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