| | Class 2 Device Recall MegaGen His Personal Lubricant |  |
| Date Initiated by Firm | February 03, 2014 |
| Date Posted | April 24, 2014 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1499-2014 |
| Recall Event ID |
67976 |
| Product Classification |
Mega-Gen His Personal Lubricant - Product Code NA
|
| Product | Mega-Gen His Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80708-3; Mega-Gen Hers Personal Lubricant, 8 fl. oz., Meta Labs, UPC Code 80808-0
Product Usage:
A topical gel that increases sexual excitement and pleasure. |
| 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 Contact | Sam Khayat 770-645-0602 |
Manufacturer Reason for Recall | Firm is not registered as a drug manufacturer. |
FDA Determined Cause 2 | 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 | 7 |
| 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. |
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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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