Z-0449-2012

Puracyn OTC; Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump)...

Name: Z-0449-2012 Puracyn OTC; Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump)...
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 Puracyn OTC; Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert. Kills 99.99% of... 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-0449-2012
Status: Terminated
Initiated: 2011-11-09
Posted: 2012-01-11
Terminated: 2012-12-07
Recalling firm: Sonoma Pharmaceuticals, Inc.
Product: Puracyn OTC; Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert. Kills 99.99% of Staph, MRSA, Strep and other Infectious Germs in 30 seconds in solution. Does not contain Antibiotics, Steroids or Alcohol. -Cleans infected wounds in one step - Safe to use around eyes, nose, m mouth and open wounds - Accelerated healing of minor wounds by keeping the wound clean -Non-toxic and non-irritating. Manufactured by Oculus Innovative Sciences for Innovaycen, Inc. 3546 N. Riverside Ave. Rialto, CA 92377 Made in USA. Intended for OTC use for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin.
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: 7894 x 8 oz pumps; 174 x 16 oz pumps
Distribution: Nationwide Distribution.
Product codes and lots: Part number: 6000;80003 (8 oz trigger spray): Lot numbers: 10E0084-01, exp 11/11; 10F0099, exp 12/11; 10F0105, exp 12/11; 041311-01, exp 5/12. Part number: 6002; 80001, (8 oz finger pump); lot number s: 041311-01, exp 5/12; 081710-01, exp.9/11; 120810-01, exp 2/2012; 073010-02, exp 11/11. Part number: 6004; 80005. 16 oz with insert: 061511-02. exp 12/12.

Product code FRO

K090206UnclassifiedOculus Puracyn Antimicrobial Skin and Wound CleanserOculus Innovative Sciences, Inc. / cleared 2009-06-02

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)