FDA Drug recall D-1402-2019
Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc
- FDA Drug
- Class II
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class II recall of Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc by Synthetopes, citing lack of Processing Controls.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1402-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-28 |
| Published | 2019-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Synthetopes |
| Distribution | US |
Product
Sulfur Colloid Reaction Vial 1.0 mL, Thaw Before Use, Not for Direct Injection, Store Frozen, Synthetopes, Inc.
Reason
Lack of Processing Controls.
Identifiers
| code_info | All 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-1402-2019%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.