Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-3042-2011

Equate Muti-Purpose Solution, For Soft Contact Lenses, Sterile, 12 Fl oz. (355 mL), Distributed by Wal-Mart...

Bausch & Lomb Incorporated / initiated 2011-06-30 / Terminated / root cause: packaging

Bausch & Lomb Inc began a recall of Equate Muti-Purpose Solution, For Soft Contact Lenses, Sterile, 12 Fl oz. (355 mL), Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716 Daily cleaning... on . The reason FDA records is "Muti-purpose solution bottles, lot GC1107 were packaged in a carton that was marked with an incorrect lot code and expiration date". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-3042-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Bausch & Lomb Incorporated
Product
Equate Muti-Purpose Solution, For Soft Contact Lenses, Sterile, 12 Fl oz. (355 mL), Distributed by Wal-Mart Stores, Inc., Bentonville, AR 72716 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
Muti-purpose solution bottles, lot GC1107 were packaged in a carton that was marked with an incorrect lot code and expiration date.
Root cause tag
packaging
FDA root cause
Packaging
Action
Bausch & Lomb Inc. notified the affected customer via teleconference and e-mail on June 30, 2011. The e-mail describes the product, problem, and actions to be taken by the customer. The customer was instructed to hold and stop shipments of any inventory of the affected product. An official recall was initiated with the customer on July 8, 2011 via e-mail and teleconference. Customer was asked to review their inventory and store returns, and send any of the affected product to Bausch & Lomb Returns Dept., 130 Commerce Drive, Greenville, SC 29615.
Quantity in commerce
1200 bottles
Distribution
Distribution-in the state of AK only
Product codes and lots
Lot number: GC1107