FDA Recall D-0555-2024

Eugia US LLC · East Windsor, NJ

Class II Ongoing 721 days on record

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

Product

Dexamethasone Sodium Phosphate injection USP, 120mg per 30mL (4mg/mL), 30 mL Multiple-Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520, Made in India, NDC 55150-239-30

Lot / code: Lot#: 3DS23001, 3DS23004, Exp 6/30/2024; 3DS23009, 3DS23011, Exp 7/31/2024

Quantity: 70,125 vials

Reason for recall

Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.

Recall record

Recall number: D-0555-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: USA Nationwide
Recall initiated: 2024-05-23
Classified by FDA Center: 2024-06-14
FDA published: 2024-06-26
Recalling firm: Eugia US LLC
Firm location: East Windsor, NJ

Drug identification

Brand name(s): DEXAMETHASONE SODIUM PHOSPHATE
Generic name(s): DEXAMETHASONE SODIUM PHOSPHATE
Manufacturer(s): Eugia US LLC
NDC(s): 55150-237, 55150-238, 55150-239
Route(s): INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRAVENOUS, SOFT TISSUE

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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