Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0126-2015Class II

Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc

Bausch & Lomb Incorporated / initiated 2014-09-25 / Terminated / root cause: manufacturing process

Bausch & Lomb Inc- Greenville Solutions Plant began a recall of Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc on . FDA classified it as Class II and gives the reason as "Product lot did not meet the specification for its disinfectants at the time of manufacture". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-0126-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Bausch & Lomb Incorporated
Product
Equate Moisture Last Multi-Purpose Solution, 2 pack, 12 fl. oz. (355 mL), Distributed by Walmart Stores, Inc.
Product code
LYL Accessories, Solution, Ultrasonic Cleaners For Lenses
Reason for recall
Product lot did not meet the specification for its disinfectants at the time of manufacture.
Root cause tag
manufacturing process
FDA root cause
Other
Action
Consignees were notified via letter starting 09/25/2014.
Quantity in commerce
18,792 bottles (9,396 twin packs)
Distribution
US Nationwide Distribution in states of: AL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, LA, MS, NC, NH, NY, OH, OR, PA, TN, TX, UT, VA, and WI.
Product codes and lots
Lot number: GBD14070 (twin packs), SKU: 630308

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0126-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0126-2015Class IITerminatedVoluntary: Firm initiated