FDAClass IIJune 19, 2019

Sn-Pyrophosphate Kit recall

Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.

Why was Sn-Pyrophosphate 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-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.
Recalling firm
Synthetopes Inc
Quantity
45 vials
Distribution
Nationwide.
Recall date
June 19, 2019
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls