Drug recall
Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton…
FDA recall event 78847 · Class I · Aurobindo Pharma Ltd.
Key facts
| Event ID | 78847 |
|---|---|
| Recall numbers | D-0339-2018 |
| Recalling firm | Aurobindo Pharma Ltd. |
| Product type | Drugs |
| Products | Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial. |
| Initiation date | Jan 2, 2018 |
| Report date | Feb 14, 2018 |
| Termination date | Sep 10, 2019 |
| City | Hyderabad |
| Country | India |
| FEI number | 3004446312 |
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: