FDA Drug recall D-0866-2018
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pha…
- FDA Drug
- Class I
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class I recall of Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pha… by Auromedics Pharma, citing presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the a….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0866-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-05-01 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Auromedics Pharma |
| Distribution | US |
Product
Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.
Reason
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
Identifiers
| ndc | 55150-116-20 |
|---|---|
| ndc | 55150-117-20 |
| ndc | 55150-178-99 |
| ndc | 55150-179-99 |
| code_info | Lot #: AS0317041-A, AS0317035-A; Exp August 2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0866-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.