AuroMedics Pharma LLC recalls Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LL…
- Recall date
- September 26, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0013-2023
- FDA classification
- Class II
- Brand / firm
- AuroMedics Pharma LLC
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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