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 conditions, by maintaining a moist wound and skin environment. General and Plastic Surgery: 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 conditions, by maintaining a moist wound and skin environment.
FDA Recall Z-0763-2017 · Posted 2016-12-14
Recalling FirmOculus Innovative Sciences, Inc.
Recall StatusTerminated
Product CodeFRO
Date Initiated2016-11-21
Date Terminated2017-06-13
Product Quantity68,970 units
Reason for Recall
Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.