CLASS I Drug recall · Reported 14 Feb 2018 · FDA Enforcement Report
Ampicillin and Sulbactam for Injection vial recalled by Aurobindo Pharma
Aurobindo Pharma is recalling Ampicillin and Sulbactam for Injection vial, sterile Dry Powder for injection, 10 vials, distributed nationwide in the US. The recall was initiated on 2 Jan 2018 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0339-2018
- FDA event ID
- 78847
- Recalling firm
- Aurobindo Pharma, Hyderabad, N/A
- Manufacturer
- Eugia US LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 2 Jan 2018
- FDA classified
- 8 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 2 Jan 2018 | Recall initiated by company | |
| 8 Feb 2018 | Classified by FDA | +37 days |
| 14 Feb 2018 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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 55150-116-20
Where it was distributed
distributed nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial.
Which lots are affected?
Lot Number AF0117001-A
Where was it sold?
distributed nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aurobindo Pharma
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Metformin Hydrochloride Tablets, USP 1000 mg recalledMetformin Hydrochloride | Aurobindo Pharma | Other | Nationwide |
| Drug | CLASS II | Northstar Zolpidem Tartrate Tablets USP 10 mg recalled | Aurobindo Pharma | Other | Nationwide |
Other Ampicillin recalls
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ampicillin and Sulbactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin for Injection, USP 500 mg per vial recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin and Sulbactam for Injection, USP per Pharmacy recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin for Injection, USP per Pharmacy recalled | Astral SteriTech Private | Sterility | Nationwide |
| Drug | CLASS II | Ampicillin and Sulbactam for Injection, USP per vial recalled | Astral SteriTech Private | Sterility | Nationwide |