Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0763-2017 — 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 incl

U.S. FDA — Device Enforcement · United States · 2016-11-21 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0763-2017
Date of alert: 2016-11-21
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Oculus Innovative Sciences, Inc.
Product category: device
Product type: Devices

Reported risk: Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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