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D-1403-2019 Class II Terminated

Recalled by Synthetopes Inc — Conway, SC

FDA drug recall D-1403-2019 was initiated by Synthetopes Inc on May 28, 2019 and is designated Class II. Reason for recall: Lack of Processing Controls. The recall status is terminated (terminated October 15, 2020). Affected quantity: 68 vials.

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: 68 vials

Product Description

Sn-d, l-Exametazime (Sn-d,l-HMPAO), Not for Direct Injection, Store Below 25 C, 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-1404-2019 Class II — Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Sy (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)
D-1399-2019 Class II — Pentreotide (10 uGm), Not for Direct Injection, Synthetopes, Inc. (May 28, 2019)