FDA Drug recall D-1551-2022
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Wind…
- FDA Drug
- Class III
- ongoing
- Published 2022-10-12
On 2022-10-12 the FDA classified a Class III recall of Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Wind… by Auromedics Pharma, citing presence of Particulate Matter: Piece of metal found in a vial.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1551-2022 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2022-09-26 |
| Published | 2022-10-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Auromedics Pharma |
| Distribution | US |
Product
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10
Reason
Presence of Particulate Matter: Piece of metal found in a vial
Identifiers
| ndc | 55150-188-10 |
|---|---|
| code_info | Lot: CTA210006, Exp. 02/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Drug · Class II · 2021-02-10 · Auromedics Pharma - Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vial, Rx Only, For Intramuscular or Intravenous Use, Not for…
FDA Drug · Class III · 2020-02-26 · Auromedics Pharma
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1551-2022%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.