Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1500-2014Class II

Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8

Altasource LLC dba Meta Labs LLC / initiated 2014-02-03 / Open, Classified / root cause: manufacturing process

Altasource LLC dba Meta Labs LLC began a recall of Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to... on . FDA classified it as Class II and gives the reason as "Firm is not registered as a drug manufacturer". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-1500-2014
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Altasource LLC dba Meta Labs LLC
Product
Nice-En-Smooth Berry Burst, 4 oz., Manufactured by Meta Labs LLC, UPC 80604-8 Product Usage: Flavored lubricant water based, condom friendly jelly used to enhance or replace a womans natural lubrication.
Product code
NA
Reason for recall
Firm is not registered as a drug manufacturer.
Root cause tag
manufacturing process
FDA root cause
No Marketing Application
Action
Meta Labs notified customers of the Voluntary Recall Notification letter on February 4, 2014. The letter requested that the products be returned. For questions call 770-645-0602.
Quantity in commerce
42
Distribution
USA Nationwide in the states of AZ, AR, CA, CO, FL, GA, ID, IL,KY, LA, MI, NE, NV, NY, NC, OH, PA, TN, TX, UT, and VA.
Product codes and lots
Lot 8-94034

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1500-2014
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1498-2014Class IIOngoingVoluntary: Firm initiated
Z-1499-2014Class IIOngoingVoluntary: Firm initiated
Z-1500-2014Class IIOngoingVoluntary: Firm initiated
Z-1501-2014Class IIOngoingVoluntary: Firm initiated