ClearanceBrief
Recall Z-0159-2010 ยท LPN Accessories, Soft Lens Products

Bausch & Lomb Inc

Bausch & Lomb ReNu Multi-Purpose Solution, 12 fl.oz. (355 ml), Bausch & Lomb, Incorporated, Rochester, NY 14609. Product is used for For the cleaning, rinsing, disinfecting, and storage of soft contact lenses.

DateNov 10, 2009 (initiated Aug 17, 2009)
StatusTerminated
ReasonDuring routine testing the product failed to meet shelf life specifications.
Root causeOther
ActionConsignees were notified by letter on/about August 17, 2009. All consignees were asked to review their inventory and return any of the affected product to Stericycle Pharmaceutical Services. For questions about the recall process or need additional shipping labels, please contact Stericycle Inc. at 1-888-345-83 16. For questions regarding this recall, please contact Bausch & Lomb's Customer Resource Center at 1-800-828-6974.
Quantity5,000 bottles
DistributionDistribution: Nationwide, Trinidad, St. Croix, St. Thomas, Aruba and Bermuda.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.