Drug recalls

Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables USA Inc, 36 Stults Ro…

Hikma Injectables USA Inc · Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.

Class ICompletedD-0508-2024
Status
Completed
City
Dayton
State
NJ
Country
United States
Classification
Class I
Product type
Drugs
Event ID
94522
Recalling firm
Hikma Injectables USA Inc
Address 1
36 Stults Rd
Postal code
08810-1540
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Distribution pattern
CO, GA, PA, SD, WA
Recall number
D-0508-2024
Reason for recall
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Recall initiation date
20240429
Center classification date
20240523
Report date
20240529
Code info
Lot #: 240310003D, Exp 6/4/2024
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

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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.