Home / Recalls / AuroMedics Pharma LLC / D-0866-2018

D-0866-2018 Class I Terminated

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-0866-2018 was initiated by AuroMedics Pharma LLC on May 1, 2018 and is designated Class I. Reason for recall: 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. The recall status is terminated (terminated Nov 6, 2024). Affected quantity: 54,720 vials.

Recall Details

Product Type: Drugs
Report Date: May 16, 2018
Initiation Date: May 1, 2018
Termination Date: Nov 6, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 54,720 vials

Product Description

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 for Recall

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.

Distribution Pattern

Nationwide in the USA and Puerto Rico

Code Information

Lot #: AS0317041-A, AS0317035-A; Exp August 2019

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0866-2018
openFDA file date: Oct 6, 2026
Loaded by RegDataLab: Oct 12, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.

Other recalls by AuroMedics Pharma LLC

D-0020-2023 Class II — Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled… (Sep 30, 2022)
D-0013-2023 Class II — Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx… (Sep 26, 2022)
D-1551-2022 Class III — Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose… (Sep 26, 2022)
D-0556-2022 Class I — Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in… (Jan 26, 2022)
D-0248-2021 Class II — Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial… (Dec 30, 2020)
D-0853-2020 Class III — Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose… (Feb 7, 2020)
D-0852-2020 Class II — Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count… (Feb 7, 2020)
D-0789-2020 Class III — Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For… (Dec 2, 2019)
D-0574-2020 Class II — Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count… (Nov 25, 2019)
D-0637-2020 Class I — Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by… (Nov 20, 2019)