May 2024 FDA Recall Dexamethasone Sodium Phosphate by Eugia Us Llc
D-0555-2024 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Eugia Us Llc on May 23, 2024 for the product Dexamethasone Sodium Phosphate. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0555-2024

Reason for Recall
Failed Impurities/Degradation Specifications: impurity sulfonic acid adduct of dexamethasone phosphate results were above spec.
Initiated
05-23-2024
Reported
06-26-2024
Quantity
70,125 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94685
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Eugia US LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

55150-237-01 Dexamethasone Sodium Phosphate
55150-238-05 Dexamethasone Sodium Phosphate
55150-239-30 Dexamethasone Sodium Phosphate