Revanesse Versa Recalled for Incorrect Expiration Date Labeling
Prollenium Medical Technologies is recalling 48,457 kits of Revanesse Versa because the product is labeled with an 18-month expiration date, but it is only approved for 12 months.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding expiration dates, which fits the rubric criteria for moderate severity involving low-risk contamination or labeling issues without reported injuries.
Plain-English summary
Prollenium Medical Technologies Inc. is recalling 48,457 kits of Revanesse Versa (PN40081). The recall was initiated due to a labeling error where the product is marked with an 18-month expiration date, despite being approved for only 12 months of use.
The affected lots were distributed nationwide in the United States, specifically in Texas, Florida, North Carolina, Louisiana, Kentucky, Wisconsin, South Dakota, Illinois, Kansas, and California. The recall covers specific lot numbers and expiration dates ranging from July 2018 to June 2019.
Consumers and healthcare providers should stop using the affected product and contact Prollenium Medical Technologies Inc. for further instructions or a refund. This recall is classified as Class II by the FDA, indicating that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Revanesse Versa, PN40081
- Manufacturer
- Prollenium Medical Technologies Inc.
- Category
- Medical Device — Dermal Filler
- Hazard
- Affected units
- 48,457
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot #/ Exp. date 17K004/July 31
- 2018 17K005/July31
- 2018 I7K006/August 31
- 2018 17K007/August 31
- 2018 17K090/October 31
- 2018 17K091/October 31
- 2018 17L026/October 31
- 2018 17L028/October 31
- 2018 I7L050/November 30
- 2018 17L0S1/November 30
- 2018 18A023/November 30
- 2018 18A024/November 30
- 2018 I8E028/December 31
- 2018 18E029/December 31
- 2018 18F032/December 31
- 2018 18F033/December 31
- 2018 18G065/April 30
- 2019 18G074/April 30
- 2019 18G075/April 30
- 2019 18G076/April 30
Distribution
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