FDAClass IIJune 19, 2019

Sn-Tetrofosmin Kit recall

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

Why was Sn-Tetrofosmin Kit recalled?

Lack of Processing Controls.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots remaining within expiry.

Product
Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Recalling firm
Synthetopes Inc
Quantity
Unknown
Distribution
Nationwide.
Recall date
June 19, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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