CVS Pharmacy One Step Cleaning & Disinfecting Solution No Rub, For soft contact lenses (hydrophilic) replaced in 30 days
FDA device recall Z-0379-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- CVS
- Reason for recall
- Product label fails to provide adequate warning for use
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LYL
- Quantity affected
- 19, 261 units
- Distribution
- Nationwide
- Date initiated
- 2003-11-20
- Date posted
- 2004-07-20
- Date terminated
- 2004-04-06
- Location
- Woonsocket, RI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SAUFLON MULTI LENS CARE SYSTEM (K010559) | Sauflon Pharmaceuticals, Ltd. | 2001-12-20 |