Z-0379-04

CVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses (hydrophilic) replaced...

Name: Z-0379-04 CVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses (hydrophilic) replaced...
Creator: Cvs
Published: 2003-11-20
License: https://open.fda.gov/license/

CVS Pharmacy, Inc. / initiated 2003-11-20 / Terminated / root cause: labeling and UDI

FDA source

CVS began a recall of CVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses (hydrophilic) replaced in 30 days or less. Contains hydrogen peroxide as... on 2003-11-20. The reason FDA records is "Product label fails to provide adequate warning for use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0379-04
Status: Terminated
Initiated: 2003-11-20
Posted: 2004-07-20
Terminated: 2004-04-06
Recalling firm: CVS Pharmacy, Inc.
Product: CVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses (hydrophilic) replaced in 30 days or less. Contains hydrogen peroxide as the disinfecting agent. 12 Fl. Oz (355 ML). [OTC] Item Number: 191648
Product code: LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Reason for recall: Product label fails to provide adequate warning for use
Root cause tag: labeling and UDI
FDA root cause: Other
Action: CVS issued a product recall on 11/19/03, from the Category Manager to Store Operations for the product to be removed from retail stores. The request listed Item # 191648, CVS One-Step Disinfecting Solution, 12 fl. oz., all lot #''s,.Individual pieces (bottles) would be returned through a third party, Carolina Logistics. An e-mail was also sent on 11/19/03 from the Quality Assurance Department to the nine CVS distribution centers requesting item # 191648 be removed from its pick line location as well as any other warehouse locations and be put on quality hold. Each distribution center was asked to return the amount of product on hand at that particular center to the quality assurance department. The product was removed from sale from the CVS.com website.
Quantity in commerce: 19, 261 units
Distribution: Nationwide
Product codes and lots: All lot codes

Product code LYL

K010559Class IISauflon Multi Lens Care SystemSauflon Pharmaceuticals, Ltd. / cleared 2001-12-20

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)