Drug recall
Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi…
FDA recall event 92341 · Class II · Astral SteriTech Private Ltd.
Key facts
| Event ID | 92341 |
|---|---|
| Recall numbers | D-0580-2023, D-0581-2023, D-0582-2023, D-0583-2023, D-0584-2023, D-0585-2023, D-0586-2023, D-0587-2023, D-0588-2023, D-0589-2023, D-0590-2023, D-0591-2023 and 40 more |
| Recalling firm | Astral SteriTech Private Ltd. |
| Product type | Drugs |
| Products | Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manufactured for: Civica Inc. Lehi Utah 84043, NDC 72572-021-10, Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-083-01, Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfd for Meitheal Pharmaceuticals Chicago, IL 60631, NDC 71288-007-75, Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-208-15, Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Package, Rx only, Mfg. for: Piramal Critical Care, Bethlehem, PA 18017 USA, NDC 66794-243-15 and 47 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | Lack of Assurance of Sterility |
| Initiation date | May 15, 2023 |
| Report date | May 24, 2023 |
| Termination date | Apr 5, 2024 |
| City | Vadodara |
| Country | India |
| FEI number | 3005508230 |
At a glance
- 10–99 Products in this recall
- 1–9 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: