Reference Source

ACRE PHARMA LIMITED · 89-08 · UNITED KINGDOM

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
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
SYNVISC ONE | Euflexxa 1% Sodium Hyaluronate each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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:

accessdata.fda.gov, retrieved 2026-09-15

Source

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