Drug recall
labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor…
FDA recall event 79265 · Class III · SCA Pharmaceuticals, LLC.
Key facts
| Event ID | 79265 |
|---|---|
| Recall numbers | D-0603-2018 |
| Recalling firm | SCA Pharmaceuticals, LLC. |
| Product type | Drugs |
| Products | labetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028 |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and… |
| Initiation date | Feb 22, 2018 |
| Report date | Mar 14, 2018 |
| Termination date | Feb 26, 2019 |
| City | Windsor |
| State | CT |
| Country | United States |
| FEI number | 3013736415 |
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: