CLASS II Drug recall · Reported 26 Oct 2022 · FDA Enforcement Report
Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial recalled
AuroMedics Pharma is recalling Acyclovir Sodium Injection, 500mg/ (50mg/mL) Single Dose Vial, distributed nationwide in the US. The recall was initiated on 26 Sep 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0013-2023
- FDA event ID
- 90896
- Recalling firm
- AuroMedics Pharma, East Windsor, NJ
- Brand
- Acyclovir Sodium
- Manufacturer
- Eugia US LLC
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 26 Sep 2022
- FDA classified
- 18 Oct 2022
- Reported
- 26 Oct 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 26 Sep 2022 | Recall initiated by company | |
| 18 Oct 2022 | Classified by FDA | +22 days |
| 26 Oct 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Which lots are affected?
Lot: AC22006, Exp 08/2023
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from AuroMedics Pharma
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fondaparinux Sodium Injection, USP, 7.5 mg per, Single Dose recalledFondaparinux Sodium | AuroMedics Pharma | Potency & Assay | Nationwide |
| Drug | CLASS III | Tranexamic Acid Injection, USP, 1000mg recalled by AuroMedics PharmaTranexamic Acid | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS I | Polymyxin B for Injection USP per Vial vials recalledPolymyxin B | AuroMedics Pharma | Particulate Matter | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1,000 mg recalled by AuroMedics PharmaAcetaminophen | AuroMedics Pharma | Other | Nationwide |
| Drug | CLASS III | Glycopyrrolate Injection, USP 4 mg recalled by AuroMedics PharmaGlycopyrrolate | AuroMedics Pharma | Potency & Assay | LA, MS, OH |
Other Acyclovir recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | acyclovir sodium, 200 mg, 200mg added recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | Acyclovir Oral Suspension, 200mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Acyclovir Sodium Injection 1,000 mg per* (50 mg/mL) recalled by Eugia USAcyclovir Sodium | Eugia US | Particulate Matter | Nationwide |
| Drug | CLASS III | Acyclovir Tablets, USP, 400 mg recalled by Heritage PharmaceuticalsAcyclovir | Heritage Pharmaceuticals | Packaging Defects | OH |
| Drug | CLASS I | Acyclovir Sodium Injection 500mg/ (50mg/mL) recalledAcyclovir | Zydus Pharmaceuticals | Packaging Defects | Nationwide |