Drug Enforcement D-0174-2025

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Status

Completed

Classification

Class II

Report Date

January 8, 2025

Termination Date

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Product Information

Product description
phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Road, Dayton, NJ 08810, NDC 63037-173-25
Product quantity
—
Reason for recall
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Hikma Injectables USA Inc
Address
36 Stults Rd

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

Recall number
D-0174-2025
Event ID
95993
Recall initiation date
December 19, 2024
Center classification date
January 2, 2025
Code info
Lot number: 243120003D, Use by Date: 03/11/2025
More code info
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