Class II · Moderate risk
acyclovir sodium
Lack of Assurance of Sterility
Acyclovir Sodium Injection 1
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Presence of Particulate Matter: Customer complaint of dark particles found inside the vial
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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
Affected NDC
55150-0155-20
Compare with the code on your package — it is the most precise check available.
Drug: Acyclovir
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Acyclovir Sodium NDC 55150-0155 |
1000 mg/20mL | Injection, Solution Intravenous |
AuroMedics Pharma LLC | Rx |
- Recalling firm
- Eugia US LLC
- NDC code
- 55150-155-20
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0095-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Acyclovir recalls
See all
Class II · Moderate risk
Acyclovir Oral Suspension
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk
Acyclovir Sodium Injection
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Class III · Low risk
Acyclovir Tablets
Labeling: Incorrect or Missing Lot and/or Exp Date
Class I · High risk
Acyclovir Sodium Injection 500mg/10mL
Crystallization: customer complaints for crystallization in finished product.
Other recalls by Eugia US LLC
All 2022 recalls
Class III · Low risk
Lidocaine HCl Injection
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Class II · Moderate risk
Gentamicin Injection
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Class II · Moderate risk
Tirofiban Hydrochloride Injection 12.5 mg/250 mL
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Class II · Moderate risk
Tirofiban Hydrochloride Injection 5 mg/100 mL
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
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