Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1026-2011

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

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

Bausch & Lomb Inc began a recall of Up&Up Multipurpose Solution, no-rub formula, 12 FL OZ (355 mL), Sterile, Distributed by Target Corporation, Minneapolis, MN 55403 Daily cleaning, removing... on . The reason FDA records is "There is a potential for some packages to not meet sterility requirements". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-1026-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Bausch & Lomb Incorporated
Product
Up&Up Multipurpose Solution, no-rub formula, 12 FL OZ (355 mL), Sterile, Distributed by Target Corporation, Minneapolis, MN 55403 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
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
Product codes and lots
Lot number: GH0078