Drug recall
Edex Diluent, (bacteriostatic 0.9% sodium chloride injection preserved with benzyl alcohol 0.945% w/v), 1.2 mL…
FDA recall event 25870 · Class II, Class III · Akorn, Inc.
Key facts
| Event ID | 25870 |
|---|---|
| Recall numbers | D-251-3, D-252-3, D-253-3, D-254-3, V-171-3 |
| Recalling firm | Akorn, Inc. |
| Product type | Drugs |
| Products | Edex Diluent, (bacteriostatic 0.9% sodium chloride injection preserved with benzyl alcohol 0.945% w/v), 1.2 mL syringe, Rx Only, Dist. by Schwarz Pharma, Inc., Milwaukee, WI 53201, Methylene Blue Injection, USP, 1%, 1mL single dose vial, 10 vials per carton, Rx only, Taylor Pharmaceuticals, Decatur, IL 62522, NDC 11098-504-01, Myochrysine, Gold Sodium Thiomalate Injection, USP, 50 mg/mL, 1 mL Single Dose Vials and 10 mL Multiple Dose Vials, Rx only, Taylor Pharmaceuticals, Decatur, IL 62522; NDC 11098-533-01 (1 mL) and…, Sarapin Injection, 50 mL vials, manufactured by Akorn, Inc., Decatur, IL 62522, Xylazine Hydrochloride Injection, 100 mg/mL, 50 mL vial, Distributed by Lloyd Laboratories, Shenandoah, IA 5160. Product is shipped unlabeled to Lloyd Labs. for labeling. |
| Classification | Class II, Class III |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of assurance of sterility, Potential non-sterility of aseptically filled injectable drugs. |
| Initiation date | Mar 26, 2003 |
| City | Decatur |
| Country | United States |
| FEI number | 1450114 |
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