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U.S. Department of Health and Human Services

Import Alert 57-16
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(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 57-16
Published Date: 03/18/2011
Type: DWPE with Surveillance
Import Alert Name:
"Purified Urokinase Powder From China Or Other Foreign Sources"

Reason for Alert:
It has recently come to CBER's attention that some bulk shipments of unapproved Urokinase purified powder identified either as a ¿sample for testing only¿ or as a ¿sample¿ entered the U.S. where it was repackaged, relabeled, and sold to a pharmacy. The pharmacy used the material to manufacture a new drug for human use and distributed the drug. There are currently no approved foreign sources of urokinase purified powder.

Guidance:
Districts may detain without physical examination Urokinase from the firms identified on this alert.

Surveillance of Urokinase from other unapproved sources is warranted.

Districts encountering imported, purified Urokinase powder should contact OCBQ/DCM, Import/Export Staff.

For questions or issues concerning science, science policy, analysis, preparation, or analytical methodology, contact the Division of Field Science.

Product Description:
Urokinase, purified powder

Charge:
"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded in that its labeling lacks adequate directions for use. [Misbranding, Section 502(f)(1)]."

OASIS charge code - DIRECTIONS

Countries

MULTIPLE COUNTRIES (PODS ONLY)
(57 A Y - 18) Urokinase
(57 Y Y - 99) Biologics and Licensed In-Vivo and In-Vitro Diagnostics, N.E.C.

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)


CHINA
Guangdong Techpool Biochem Pharma (GTBP)
Date Published : 09/10/2009

12 Jianzhong Rd , Guangdong, CHINA
57 A Y - 18 Urokinase
Date Published: 09/10/2009

57 Y Y - 99 Biologics and Licensed In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/10/2009


Luye Pharmaceutical Co., Ltd.
Date Published : 09/10/2009

No. 9 Baoyuan Road , Laishan district , Yantai, Shandong CHINA
57 A Y - 18 Urokinase
Date Published: 09/10/2009

57 Y Y - 99 Biologics and Licensed In-Vivo and In-Vitro Diagnostics, N.E.C.
Date Published: 09/10/2009


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