Drug recall D-0013-2023

Class II Completed reported Oct 26, 2022

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.

Reason for recall

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

Lots and codes

Lot: AC22006, Exp 08/2023

Recall details

Recalling firm
AuroMedics Pharma LLC, East Windsor, NJ
Quantity
89400 vials
Distribution
Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
September 26, 2022

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