Drug Enforcement D-0013-2023

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

1 Views

Status

Completed

Classification

Class II

Report Date

October 26, 2022

Termination Date

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Product Information

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.
Product quantity
89400 vials
Reason for recall
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
AuroMedics Pharma LLC
Address
279 Princeton Hightstown Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0013-2023
Event ID
90896
Recall initiation date
September 26, 2022
Center classification date
October 18, 2022
Code info
Lot: AC22006, Exp 08/2023
More code info
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