Synthetopes Inc: Various Radiopharmaceutical Cold Kits Recalled for Lack of Processing Controls

What You Should Do

1. Check your medical inventory for the following Synthetopes, Inc. products: Pentreotide (Recall D-1399-2019), Sn-DMSA (Recall D-1400-2019), Sn-Mertiatide (Recall D-1401-2019), Sulfur Colloid (Recall D-1402-2019), Sn-d,l-HMPAO (Recall D-1403-2019), Sn-DTPA (Recall D-1404-2019), Sn-Tetrofosmin (Recall D-1405-2019), or Sn-Pyrophosphate (Recall D-1406-2019).
2. Verify if the vials are currently within their expiration date, as all lots remaining within expiry are affected by this recall.
3. Immediately stop using any of these products and quarantine all affected vials to prevent their use in medical procedures.
4. Contact your healthcare provider, pharmacist, or the medical facility where these products were sourced to discuss alternative options and receive guidance on patient care.
5. Return any unused vials to the place of purchase for a refund and contact Synthetopes Inc. directly at their Conway, South Carolina facility for specific return instructions.
6. For additional information or to report concerns, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Affected Products