ACRE PHARMA LIMITED · 89-08 · UNITED KINGDOM
For ACRE PHARMA LIMITED, import alert is 89-08; country is UNITED KINGDOM; 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)"; product is Euflexxa 1% Sodium Hyaluronate | SYNVISC ONE; 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 2026-09-30.
- Firm
- ACRE PHARMA LIMITED verified
- 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
- Address
- Unit 5-7 , Tintagel , Walsall, UNITED KINGDOM verified
- Date published
- 03/02/2023 verified
- Product code
- 87 M - - OZ Acid, hyaluronic, intraarticular | 87 M - - OZ Acid, hyaluronic, intraarticular each item verified
- Product
- Euflexxa 1% Sodium Hyaluronate | SYNVISC ONE each item verified
What the source says
ACRE PHARMA LIMITED Date Published : 03/02/2023 Unit 5-7 , Tintagel , Walsall, UNITED KINGDOM
— accessdata.fda.gov, retrieved 2026-09-22
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code and Product
87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 03/02/2023 Desc: Euflexxa 1% Sodium Hyaluronate Notes: 87 M - - OZ Acid, hyaluronic, intraarticular Date Published: 05/11/2023 Desc: SYNVISC ONE Notes:
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html