FDA Medical Device Recalls (openFDA)
CVS: 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
- Recall number
- Z-0379-04
- Recalling firm
- CVS
- 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
- Status
- Terminated
- Initiated
- 2003-11-20
- Posted
- 2004-07-20
- Terminated
- 2004-04-06
- Reason
- Product label fails to provide adequate warning for use
- 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
- 19, 261 units
- Distribution
- Nationwide
- Lot, serial or model codes
- All lot codes
- 510(k) numbers
- ["K010559"]
- PMA numbers
- not on file
- Product code
- LYL
- Firm FEI
- 1217081
- Firm city
- Woonsocket
- Firm state
- RI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28