Z-0451-2012

Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz. Provided Pain Relief, Relieve Itch, Reduces symptoms...

Name: Z-0451-2012 Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz. Provided Pain Relief, Relieve Itch, Reduces symptoms...
Creator: Oculus Innovative Sciences Inc
Published: 2011-11-09
License: https://open.fda.gov/license/

Sonoma Pharmaceuticals, Inc. / initiated 2011-11-09 / Terminated / root cause: manufacturing process

FDA source

Oculus Innovative Sciences Inc began a recall of Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz. Provided Pain Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation, Provide a... on 2011-11-09. The reason FDA records is "Unapproved drug claims and those not approved under 510K clearance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0451-2012
Status: Terminated
Initiated: 2011-11-09
Posted: 2012-01-11
Terminated: 2012-12-07
Recalling firm: Sonoma Pharmaceuticals, Inc.
Product: Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz. Provided Pain Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation, Provide a protective shield against contamination. Antibiotic-free, steroid-free and biodegradable.. Oculus Innovative Sciences . Petaluma, CA 94954. Intended for use by health care professionals in management of wounds including itch and pain relief associated with dermal irritation, sore, injuries and ulcers or dermal tissue. Microcyn Skin and Wound hydrogel is intended for use on first and second degree burns, excluding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
Product code: FRO Dressing, Wound, Drug
Reason for recall: Unapproved drug claims and those not approved under 510K clearance.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Oculus Innovative Sciences sent an"URGENT MEDICAL DEVICE RECALL" letter dated November 15, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to identify and remove all affected product from inventory. A Business Reply Card was attached to the letter for customers to complete and return via fax to 1-415-462-5181. Call Oculus Innovative Sciences Customer Service at 1-800-759-9305 for questions regarding this recall.
Quantity in commerce: 4343 x 1.76 oz; 1.76 oz, 541 x 4 oz.
Distribution: Nationwide Distribution.
Product codes and lots: Part number: 84811 - 1.76 oz. Lot numbers: 10C0030-03, exp 3/12; 10C0034-03, exp 3/12; 10D0051-01, exp 4/12; 10D0059-02, exp 4/12; 10E0076-01, exp 5/12; 10H0112-03, exp 8/12; 10H0116-03, exp 8/12; 10J0143-02, exp 10/12; 11B0051-01, exp 2/13. Part number 84828, 4 oz. lot 10C0032, exp 3/12.

Product code FRO

K093585UnclassifiedMicrocyn Skin and Wound HydrogelOculus Innovative Sciences, Inc. / cleared 2010-03-08

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)