FDA Drug recall D-0510-2017
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 Ph…
- FDA Drug
- Class II
- terminated
- Published 2017-03-15
On 2017-03-15 the FDA classified a Class II recall of 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 Ph… by Leo Pharma, citing 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 prod….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0510-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-19 |
| Published | 2017-03-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Leo Pharma |
| Distribution | US |
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
Reason
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.
Identifiers
| ndc | 66993-877-61 |
|---|---|
| ndc | 66993-877-78 |
| 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; A2…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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0510-2017%22
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