Up&Up Multipurpose Solution, no-rub formula, 12 FL OZ (355 mL), Sterile, Distributed by Target Corporation, Minneapolis,

FDA device recall Z-1026-2011 · posted 2011-02-02 · Terminated

Recall details

Recalling firm

Bausch & Lomb Inc

Reason for recall

There is a potential for some packages to not meet sterility requirements.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LYL

Quantity affected

67,296 12 oz Bottles (33,648 twin packs)

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

Date initiated

2010-12-22

Date posted

2011-02-02

Date terminated

2012-09-04

Location

Rochester, NY