Z-1025-2011

Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Manufactured by: Bausch & Lomb...

Name: Z-1025-2011 Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Manufactured by: Bausch & Lomb...
Creator: Bausch & Lomb Inc
Published: 2010-12-22
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2010-12-22 / Terminated / root cause: packaging

FDA source

Bausch & Lomb Inc began a recall of Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Manufactured by: Bausch & Lomb Place, Rochester, NY 14609 Daily cleaning... on 2010-12-22. The reason FDA records is "There is a potential for some packages to not meet sterility requirements". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1025-2011
Status: Terminated
Initiated: 2010-12-22
Posted: 2011-02-02
Terminated: 2012-09-04
Recalling firm: Bausch & Lomb Incorporated
Product: Bausch & Lomb, Renu Fresh Multi-purpose Solution, 2 fl oz (60 mL), Travel Kit, Manufactured by: Bausch & Lomb Place, Rochester, NY 14609 Daily cleaning, removing protein deposits, rinsing, chemical (not heat) disinfection, and storage of soft (hydrophilic) contact lenses.
Product code: LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Reason for recall: There is a potential for some packages to not meet sterility requirements.
Root cause tag: packaging
FDA root cause: Other
Action: On December 8, 2010, Target was visited by FDA/PHI-DO and was informed on the violation. The Target customers that received lot GH0078 were requested to return all affected product directly to the Bausch & Lomb Greenville, SC Distribution Center. Bausch and Lomb sent an Urgent Voluntary Medical Device Recall to all first consignees who were shipped the affected lot GH0066 of Renu Fresh Multipurpose Solution on/about December 22, 2010. Since Target customers had already been notified previously regarding lot GH0078, this lot number was not included in the subsequent recall notification. All consignees were requested to review their inventory, and return any of the affected product to Stericycle Pharmaceutical Services, 2670 Executive Drive, Indianapolis, IN 46241. Stericycle is conducting this recall under the control of Bausch & Lomb. For questions abut the recall process contact Stericycle, Inc. at 1-888-345-8316. For questions regarding this recall call 1-800-828-6974.
Quantity in commerce: 146,496/ 2 oz Bottles
Distribution: Worldwide Distribution - USA including AL, CA, CT, FL, GA, HI, IA, IN, LA, MA, MI, NE, NJ, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WI and the countries Taiwan and Brazil
Product codes and lots: Lot number: GH0066

Product code LYL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)