Prollenium Medical Technologies Inc. recalls Revanesse Versa, PN40081
- Recall date
- November 15, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1146-2020
- FDA classification
- Class II
- Brand / firm
- Prollenium Medical Technologies Inc.
- Sold / distributed
- US Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA
Why it was recalled
Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Revanesse Versa, PN40081
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