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

D-0866-2018 Class I Terminated

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

Recall Details

Product Type
Drugs
Report Date
May 16, 2018
Initiation Date
May 1, 2018
Termination Date
November 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

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 Sy (September 30, 2022)
  • D-0013-2023 Class II — Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx onl (September 26, 2022)
  • D-1551-2022 Class III — Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose v (September 26, 2022)
  • D-0556-2022 Class I — Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in (January 26, 2022)
  • D-0248-2021 Class II — Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vial, (December 30, 2020)
  • D-0852-2020 Class II — Amoxicillin and Clavulanate Potassium Tablets, USP, 875 mg/125 mg, 20-count bott (February 7, 2020)
  • D-0853-2020 Class III — Glycopyrrolate Injection, USP 4 mg per 20 mL (0.2 mg/mL), 20 mL Multiple Dose Vi (February 7, 2020)
  • D-0789-2020 Class III — Moxifloxacin Ophthalmic Solution USP, 0.5%, Sterile, 3mL Bottle, Rx Only, For To (December 2, 2019)
  • D-0574-2020 Class II — Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count (November 25, 2019)
  • D-0636-2020 Class I — Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Au (November 20, 2019)