Recall Z-0763-2017 ยท FRO Dressing, Wound, Drug
Oculus Innovative Sciences, Inc.
Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditi
| Date | Dec 14, 2016 (initiated Nov 21, 2016) |
| Status | Terminated |
| Reason | Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product. |
| Root cause | Packaging process control |
| Action | Oculus issued Medical Device Recall letters dated November 21, 2016, to Sales reps notifying them to stop all further distribution and immediately remove the affected lots of Recall product from sample inventory. Customers were also instructed to sign the Response form verifying receipt of the letter. Customers with questions were instructed to call Oculus Innovative Science-Regulatory Affairs at 707-559-7181. For questions regarding this recall call 559-7191. |
| Quantity | 68,970 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152055 | Ceramax Skin Barrier Cream Oculus Innovative Sciences, Nov 23, 2015 |