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D-0013-2023 Class II

Recalled by AuroMedics Pharma LLC — East Windsor, NJ

FDA drug recall D-0013-2023 was initiated by AuroMedics Pharma LLC on Sep 26, 2022 and is designated Class II. Reason for recall: Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial. Affected quantity: 89400 vials.

Recall Details

Product Type: Drugs
Report Date: Oct 26, 2022
Initiation Date: Sep 26, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 89400 vials

Product Description

Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10.

Reason for Recall

Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.

Distribution Pattern

Nationwide in the USA

Code Information

Lot: AC22006, Exp 08/2023

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0013-2023
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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