Key Takeaway

Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc. by Synthetopes Inc was recalled on May 28, 2019. The hazard: Lack of Processing Controls.

FDA Drug Class II Terminated

Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.

Recalled: May 28, 2019 ~20 vials units affected D-1399-2019

Description

Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.

Hazard / Reason

Lack of Processing Controls.

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc.

Drugs

Company Information

Synthetopes Inc

Conway, SC, United States

View all 8 recalls by Synthetopes Inc →

Distribution

Nationwide.

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Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.

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

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Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc.

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FDA Drug Class II

Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.

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FDA Drug Class II

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

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

Check the remedy section above or contact the manufacturer directly for current remedy options.

Where can I find the original recall notice?

This recall was issued by FDA Drug. Visit the agency's official website for the original notice.

Data sourced from FDA Drug Enforcement. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.