FDA-Drug2022-10-26Class II
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.
AuroMedics Pharma LLC
Hazard
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Sold states
Nationwide in the USA
Affected count
89400 vials
Manufactured in
279 Princeton Hightstown Rd, N/A, East Windsor, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0013-2023Don't want to check this manually?
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