Recall Z-1554-2014 ยท LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Bausch & Lomb Inc- Greenville Solutions Plant
Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
| Date | May 6, 2014 (initiated Apr 21, 2014) |
| Status | Terminated |
| Reason | Out of specification results for one of the two disinfectants. |
| Root cause | Nonconforming Material/Component |
| Action | Consignees were notified via registered mail starting 04/21/2014. |
| Quantity | 256,440 bottles |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083757 | BPZ02 MULTIPURPOSE SOLUTION Bausch & Lomb, Inc., Nov 18, 2009 |