Drug recall
Epinephrine injection, USP, auto-injector 0.3 mg, Rx only, For Subcutaneous or Intramuscular Use Only…
FDA recall event 57087 · Class II · Shionogi Pharma, Inc.
Key facts
| Event ID | 57087 |
|---|---|
| Recall numbers | D-109-2011, D-110-2011, D-111-2011 |
| Recalling firm | Shionogi Pharma, Inc. |
| Product type | Drugs |
| Products | Epinephrine injection, USP, auto-injector 0.3 mg, Rx only, For Subcutaneous or Intramuscular Use Only, Distributed by: Greenstone LLC, Peapack, NJ 07977; NDC: 59762-0171-1, Epinephrine injection, USP, auto-injector 0.3 mg, Two-Pack, Rx only, For Subcutaneous or Intramuscular Use Only, Distributed by: Greenstone LLC, Peapack, NJ 07977; NDC: 59762-0171-2, Twinject¿ (epinephrine injection, USP, 1:1000) auto-injector 0.3 mg, Two Pack, Rx only, For Subcutaneous or Intramuscular Use Only, Manufactured for and Distributed by: Shionogi Pharma, Inc., Atlanta… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility: Possibility exists a small number of sheaths covering the needle may have pinholes. |
| Initiation date | Oct 28, 2010 |
| Termination date | Jan 13, 2012 |
| City | Atlanta |
| State | GA |
| Country | United States |
| FEI number | 3004530896 |
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