Drug Enforcement D-0508-2024

Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Status

Completed

Classification

Class I

Report Date

May 29, 2024

Termination Date

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Product Information

Product description
Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Road, Dayton, NJ 08810, NDC 63037-123-25
Product quantity
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Reason for recall
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
CO, GA, PA, SD, WA

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-0508-2024
Event ID
94522
Recall initiation date
April 29, 2024
Center classification date
May 23, 2024
Code info
Lot #: 240310003D, Exp 6/4/2024
More code info
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