Recall: D-0013-2023

Class II - Potentially Harmful

Class IIClassification

2022-09-26Initiated

CompletedStatus

AuroMedics Pharma LLCFirm

Product

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

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

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.