FDA-Drug2019-06-19Class II

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

Synthetopes Inc
Hazard

Lack of Processing Controls.

Sold states
Nationwide.
Affected count
45 vials
Manufactured in
216 Earnhardt St, N/A, Conway, SC, United States
Products
Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1406-2019

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