Drug recall
Enoxaparin Sodium Injection, USP, 100mg/mL, Single Dose Syringes with Automatic Safety Device, For…
FDA recall event 60429 · Class II · Sandoz, Inc
Key facts
| Event ID | 60429 |
|---|---|
| Recall numbers | D-868-2012, D-869-2012 |
| Recalling firm | Sandoz, Inc |
| Product type | Drugs |
| Products | Enoxaparin Sodium Injection, USP, 100mg/mL, Single Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only, Ten 1 mL Syringes per Carton (NDC Carton 0781-3500-69, NDC Syringe…, Enoxaparin Sodium Injection, USP, 150mg/mL, Single Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only, Ten 1 mL Syringes per Carton (NDC carton 0781-3655-69 , NDC Syringe… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: Needle of packaged pre-filled syringes may be protruding through the needle guard. |
| Initiation date | Nov 17, 2011 |
| Termination date | Jan 9, 2013 |
| City | Princeton |
| State | NJ |
| Country | United States |
| FEI number | 3006697677 |
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