Drug recall
curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe Administration Kit…
FDA recall event 81504 · Class II · Bound Tree Medical, LLC
Key facts
| Event ID | 81504 |
|---|---|
| Recall numbers | D-0371-2019 |
| Recalling firm | Bound Tree Medical, LLC |
| Product type | Drugs |
| Products | curaplex Epi Safe Administration and Training Kits # 8600-01100. Kit contains 2 Epi Safe Administration Kit (8600-01101) and 1 Epi Safe Training Kit (8600-01102), Rx Only. Distributed by Sarnova HC… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling: Incorrect or Missing Lot and/or Exp date: vials of epinephrine within kit 8600-01100 expired on December 2018, but the outer kit label has an expiration date of January 2020. In addition… |
| Initiation date | Nov 1, 2018 |
| Report date | Jan 23, 2019 |
| Termination date | Jan 24, 2020 |
| City | Dallas |
| State | TX |
| Country | United States |
| FEI number | 3013654137 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: