Drug recall
Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25…
FDA recall event 80425 · Class II · SCA Pharmaceuticals
Key facts
| Event ID | 80425 |
|---|---|
| Recall numbers | D-0918-2018 |
| Recalling firm | SCA Pharmaceuticals |
| Product type | Drugs |
| Products | Buffered Lidocaine 1% with Sodium Bicarbonate Injection for Local Anesthetic Use (Concentration=10 mg/mL) 0.25 mL Total Volume, Rx only , SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Subpotent Drug: Stability data does not support the current expiration dating of 55 days after compounding. |
| Initiation date | Jun 29, 2018 |
| Report date | Jul 18, 2018 |
| Termination date | May 1, 2019 |
| City | Little Rock |
| State | AR |
| Country | United States |
| FEI number | 3010683157 |
At a glance
- 1–9 Products in this recall
- 1–9 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: