Z-0763-2017Class II

Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the...

Name: Z-0763-2017 Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the...
Creator: Oculus Innovative Sciences, Inc.
Published: 2016-11-21
License: https://open.fda.gov/license/

Sonoma Pharmaceuticals, Inc. / initiated 2016-11-21 / Terminated / root cause: packaging

FDA source

Oculus Innovative Sciences, Inc. began a recall of 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... on 2016-11-21. FDA classified it as Class II and gives the reason as "Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0763-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-21
Posted: 2016-12-14
Terminated: 2017-06-13
Recalling firm: Sonoma Pharmaceuticals, Inc.
Product: 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.
Product code: FRO Dressing, Wound, Drug
Reason for recall: Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.
Root cause tag: packaging
FDA 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 in commerce: 68,970 units
Distribution: Nationwide Distribution
Product codes and lots: Lot 3045639, expiration date: 01/2018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0763-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0763-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-21	2016-12-14

Product code FRO

K152055UnclassifiedCeramax Skin Barrier CreamOculus Innovative Sciences / cleared 2015-11-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)