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Terminated

Revanesse Versa, PN40081

FDA Recall Z-1146-2020 · Posted None

Recalling FirmProllenium Medical Technologies Inc.
Recall StatusTerminated
Product CodeLMH
Date Initiated2018-11-15
Date Terminated2024-03-22
Product Quantity48,457 kits

Reason for Recall

Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.

Firm Action

A letter containing the subject "Revanesse Versa Expiration Dating" was e-mail on Nov 15, 2018 and April 30, 2019 to all consignees. The letter informed consignees about the issue. The letter asked consignees to do the following: 1. We request you to verily if any Revanesse Versa kit lots listed in the table on Page 2 are in your possession, if so please set aside and do not use them if they are expired from their 12 month expiration date has passed. If you have any concerns with your existing Revanesse Versa kits, please ^ contact Prollenium with the information below. We will send you a shipping label that will allow you to send the product back to our distribution center. 2. Send email to info@prolIenium,com configured as follows: Business Name: XXX, Versa Lot #: XXX, Number of Expired Kits: XXX, Contact Person: XXX 3. Prollenium will inform you once the updated expiration date is approved by the US FDA.

Root Cause

Other

Distribution Pattern

US Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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