Food, drugs, devices › Aurobindo Pharma Ltd.
Drug recall: Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by
FDA enforcement event 78847 is a drug recall by Aurobindo Pharma Ltd. of Hyderabad, N/A, initiated 2 Jan 2018 and classified Class I, with 1 product record.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 11% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 10 Sep 2019. Initiation: voluntary: firm initiated. Aurobindo Pharma Ltd. has 3 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Aurobindo Pharma Ltd., Hyderabad, N/A, India.
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."
Distribution
"distributed nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0339-2018 | 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 | 53,040 vials | Class I | Terminated | 14 Feb 2018 |
Context
Other enforcement events for Aurobindo Pharma Ltd.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 2 Feb 2018 | Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc. 2 | Drug | Class III | 1 |
| 9 Mar 2012 | Northstar Zolpidem Tartrate Tablets USP 10 mg. Manufactured for Northstar RX, LLC Memphis, TN 38141. Manufactured by Aur | Drug | Class II | 1 |
All 3 events for Aurobindo Pharma Ltd.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial."
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "distributed nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Sep 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.