Drug recall
Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC…
FDA recall event 74883 · Class II · Allergy Laboratories, Inc.
Key facts
| Event ID | 74883 |
|---|---|
| Recall numbers | D-1498-2016 |
| Recalling firm | Allergy Laboratories, Inc. |
| Product type | Drugs |
| Products | Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted. |
| Initiation date | Aug 10, 2016 |
| Report date | Sep 14, 2016 |
| Termination date | Mar 13, 2017 |
| City | Oklahoma City |
| State | OK |
| Country | United States |
| FEI number | 1621802 |
At a glance
- 1–9 Products in this recall
- 10–99 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: