Acyclovir Sodium Injection, Solution
FDA Recall NDC 55150-155
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Acyclovir Sodium (NDC 55150-155). A significant event, classified as Class II, was initiated on Dec 28, 2022 by Eugia Us Llc. The reported reason for this action was: "Presence of Particulate Matter: Customer complaint of dark particles found inside the vial"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Dec 28, 2022
Jan 11, 2023
45,250 vials
Recall Profile & Regulatory Data
Event ID
91406
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Eugia US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20
Batch or Lot Expiration Information
Lot# AC22004, Expiry: 08/2023
Affected Packages Involved in this Recall
55150-154-10Product
55150-155-20Product
Class II Completed
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Sep 26, 2022
Oct 26, 2022
89400 vials
Recall Profile & Regulatory Data
Event ID
90896
Classification
Class II
Enforcement Status
Completed
Recalling Firm
AuroMedics Pharma LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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.
Batch or Lot Expiration Information
Lot# Lot: AC22006, Exp 08/2023
Affected Packages Involved in this Recall
55150-154-10Product
55150-155-20Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
