RecallRadar

FDA Drug recall D-1404-2019

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

On 2019-06-19 the FDA classified a Class II recall of Sn-DTPA Kit 10 mg, DTPA, Not for Direct Injection, Store at Room Temperature, Synthetopes, Inc by Synthetopes, citing lack of Processing Controls.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1404-2019
ClassificationClass II
Statusterminated
Initiated2019-05-28
Published2019-06-19
Last updated2026-09-13 11:52 UTC
CompanySynthetopes
DistributionUS

Product

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

Reason

Lack of Processing Controls.

Identifiers

code_infoAll lots remaining within expiry.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1404-2019%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.