FindMyRecallSubscribe
Class II: temporary or reversible health riskCompleted

AuroMedics Pharma Acyclovir Sodium Injection Recall

Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Dist…

AuroMedics Pharma LLC · East Windsor, NJ

Risk level
Class II
Reported by FDA
Oct 26, 2022
Recall ID
D-0013-2023
Check your lot numberHow we source this data

Summary

AuroMedics Pharma recalled Acyclovir Sodium Injection starting Sep 26, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0013-2023 on Oct 26, 2022. Reason: Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial. Status: Completed.

Why it was recalled

Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.

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.

Lot numbers, UPCs & expiration codes

Lot: AC22006, Exp 08/2023

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0013-2023
Classification
Class II
Status
Completed
Recall initiated
Sep 26, 2022
FDA report date
Oct 26, 2022
Quantity
89400 vials
Recall type
Voluntary: Firm initiated
Recalling firm
AuroMedics Pharma LLC

Original FDA data

Every field from FDA enforcement report D-0013-2023, exactly as published.

Show all FDA fields
City
East Windsor
State
NJ
Status
Completed
Country
United States
Event ID
90896
Address
279 Princeton Hightstown Rd
Code information
Lot: AC22006, Exp 08/2023
Postal code
08520-1401
Report date
Oct 26, 2022
Product type
Drugs
Recall number
D-0013-2023
Classification
Class II
Recalling firm
AuroMedics Pharma LLC
Product quantity
89400 vials
Reason for recall
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide in the USA
Recall initiation date
Sep 26, 2022
Initial firm notification
Letter
Center classification date
Oct 18, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0013-2023, published Oct 26, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls