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U.S. Department of Health and Human Services

Class 2 Device Recall NiceEnSmooth Berry Burst

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 Class 2 Device Recall NiceEnSmooth Berry Burstsee related information
Date Initiated by FirmFebruary 03, 2014
Date PostedApril 24, 2014
Recall Status1 Open3, Classified
Recall NumberZ-1500-2014
Recall Event ID 67976
Product Classification Nice-En-Smooth Berry Burst - Product Code NA
ProductNice-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.
Code Information Lot 8-94034
FEI Number 3006271709
Recalling Firm/
Manufacturer		 Altasource LLC dba Meta Labs LLC
1009 Mansell Rd Ste J
Roswell GA 30076-4806
For Additional Information ContactSam Khayat
770-645-0602
Manufacturer Reason
for Recall		Firm is not registered as a drug manufacturer.
FDA Determined
Cause 2		No Marketing Application
ActionMeta 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 Commerce42
DistributionUSA 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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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