FDA recall D-0013-2023

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 for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Completed

Initiation date

2022-09-26

Report date

2022-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0013-2023