# ACRE PHARMA LIMITED · 89-08 · UNITED KINGDOM — FDA import alert red lists: firms subject to detention without physical examination

For ACRE PHARMA LIMITED · 89-08 · UNITED KINGDOM, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is UNITED KINGDOM; product is SYNVISC ONE | Euflexxa 1% Sodium Hyaluronate; product code is 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular; date published is 03/02/2023; address is Unit 5-7 , Tintagel , Walsall, UNITED KINGDOM, verified against its source on 2026-09-16.

- **Firm:** ACRE PHARMA LIMITED _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
- **Country:** UNITED KINGDOM _(verified: appears in the quote below)_
- **Address:** Unit 5-7 , Tintagel , Walsall, UNITED KINGDOM _(verified: appears in the quote below)_
- **Date published:** 03/02/2023 _(verified: appears in the quote below)_
- **Product code:** 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular _(verified: each item appears in the quote below)_
- **Product:** SYNVISC ONE | Euflexxa 1% Sodium Hyaluronate _(verified: each item appears in the quote below)_

## What the source says

> ACRE PHARMA LIMITED Date Published : 03/02/2023 Unit 5-7 , Tintagel , Walsall, UNITED KINGDOM 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 05/11/2023 Desc: SYNVISC ONE Notes: 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 03/02/2023 Desc: Euflexxa 1% Sodium Hyaluronate Notes:

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).