Recall Z-0553-2010 ยท MRC Products, Contact Lens Care, Rigid Gas Permeable
Bausch & Lomb Inc
Bausch & Lomb Boston Conditioning Solution, Original Formula, Bausch & Lomb Incorporated, Rochester, NY 14609. The product is packed in 1 fl oz (30 mL), 3 fl oz (90 mL), 3.5 fl oz (105 mL) and 4 fl oz (120 ml) bottles.
| Date | Dec 22, 2009 (initiated Oct 30, 2009) |
| Status | Terminated |
| Reason | The product failed to meet Out of Specification shelf life at the 9 months time point. This could result in increased risk of an ocular infection, especially in the presence of other contributing or risk factors. |
| Root cause | Other |
| Action | Consignees were notified by mail on/about 11/06/2009. All consignees were asked to review their inventory, and return any of the affected products to Stericycle Pharmaceutical Services. A Business Reply Card was included to be returned via US mail within 5 days. A packing slip was provided to be affixed to a pre-paid USP shipping label for return. |
| Quantity | 159,672 bottles |
| Distribution | U.S. Nationwide, Canada and Hong Kong |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K983836 | RIGID GAS PERMEABLE CONTACT LENS SOLUTION Polymer Technology Div. Wilmington Partners, L.P., Feb 11, 1999 |