FDAClass IIOctober 26, 2022

Acyclovir Sodium Injection recall: Particulate Matter

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.

Why was Acyclovir Sodium Injection recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: AC22006, Exp 08/2023

Product
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.
Recalling firm
AuroMedics Pharma LLC
Quantity
89400 vials
Distribution
Nationwide in the USA
Recall date
October 26, 2022
Classification
Class II
Status
Completed
Agency
FDA (drug)
Open FDA enforcement record Latest recalls