September 2022 FDA Recall Acyclovir Sodium by Auromedics Pharma Llc
D-0013-2023 - Presence of Particulate Matter
This Class II drug recall was voluntarily initiated by Auromedics Pharma Llc on September 26, 2022 for the product Acyclovir Sodium. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0013-2023
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
09-26-2022
10-26-2022
89400 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
AuroMedics Pharma LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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.
Batch or Lot Expiration Information
Lot# Lot: AC22006, Exp 08/2023
