Home / Recalls / Synthetopes Inc / D-1404-2019

D-1404-2019 Class II Terminated

Recalled by Synthetopes Inc — Conway, SC

Recall Details

Product Type
Drugs
Report Date
June 19, 2019
Initiation Date
May 28, 2019
Termination Date
October 15, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
82 vials

Product Description

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

Reason for Recall

Lack of Processing Controls.

Distribution Pattern

Nationwide.

Code Information

All lots remaining within expiry.

Other recalls by Synthetopes Inc

  • D-1399-2019 Class II — Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc. (May 28, 2019)
  • D-1403-2019 Class II — Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, (May 28, 2019)
  • D-1405-2019 Class II — Sn-Tetrofosmin Kit 5.0 mL, Thaw and Vent before use, Not for Direct Injection, S (May 28, 2019)
  • D-1401-2019 Class II — Sn-Mertiatide Kit,1 milligram betiatide, Not for Direct Injection, Store at Room (May 28, 2019)
  • D-1406-2019 Class II — Sn-Pyrophosphate Kit, 11.9 mg sodium pyrophosphate, Not for Direct Injection, St (May 28, 2019)
  • D-1400-2019 Class II — Sn-DMSA solution, Store Frozen, Not for Direct Injection, Synthetopes, Inc. (May 28, 2019)
  • D-1402-2019 Class II — Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, (May 28, 2019)