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D-1030-2018 Class I Terminated

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-1030-2018 was initiated by AuroMedics Pharma LLC on Jul 2, 2018 and is designated Class I. Reason for recall: Presence of Particulate Matter: identified as glass and silicone material The recall status is terminated (terminated Oct 1, 2024). Affected quantity: 73620 single-dose vials.

Recall Details

Product Type: Drugs
Report Date: Jul 18, 2018
Initiation Date: Jul 2, 2018
Termination Date: Oct 1, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 73620 single-dose vials

Product Description

Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30

Reason for Recall

Presence of Particulate Matter: identified as glass and silicone material

Distribution Pattern

Nationwide in the USA

Code Information

Lot: PP0317059-A; Exp February 2019: PP0317012-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-1030-2018
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.

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