FDA Recall D-0095-2023

Eugia US LLC · East Windsor, NJ

Class II Ongoing 1233 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20

Lot / code: Lot # AC22004, Expiry: 08/2023

Quantity: 45,250 vials

Reason for recall

Presence of Particulate Matter: Customer complaint of dark particles found inside the vial

Recall record

Recall number: D-0095-2023
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2022-12-28
Classified by FDA Center: 2023-01-03
FDA published: 2023-01-11
Recalling firm: Eugia US LLC
Firm location: East Windsor, NJ

Drug identification

Brand name(s): ACYCLOVIR SODIUM
Generic name(s): ACYCLOVIR SODIUM
Manufacturer(s): Eugia US LLC
NDC(s): 55150-154, 55150-155
Route(s): INTRAVENOUS

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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