Recall Z-0379-04 ยท LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
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
| Date | Jul 20, 2004 (initiated Nov 20, 2003) |
| Status | Terminated |
| 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 a |
| Quantity | 19, 261 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010559 | SAUFLON MULTI LENS CARE SYSTEM Sauflon Pharmaceuticals, Ltd., Dec 20, 2001 |