PlainRecalls
FDA Drug Moderate Class II Terminated

Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.

Reported: June 19, 2019 Initiated: May 28, 2019 #D-1405-2019

Product Description

Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.

Reason for Recall

Lack of Processing Controls.

Details

Recalling Firm
Synthetopes Inc
Units Affected
Unknown
Distribution
Nationwide.
Location
Conway, SC

Frequently Asked Questions

What product was recalled?
Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.. Recalled by Synthetopes Inc. Units affected: Unknown.
Why was this product recalled?
Lack of Processing Controls.
Which agency issued this recall?
This recall was issued by the FDA Drug on June 19, 2019. Severity: Moderate. Recall number: D-1405-2019.