Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5mL syringe, Rx only, Hikma Injectables US
Summary
The FDA issued a Class I for Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL, 5m by Hikma Injectables USA Inc. Reason: Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine..
Details
Source
Drug Recall
External ID
D-0508-2024
Action Date
2024-05-29
Status
Completed
Category
drug
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
Lot/Code Info: Lot #: 240310003D, Exp 6/4/2024
Reason for Recall
Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine.
Distribution
CO, GA, PA, SD, WA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-29
Company
Dayton, NJ
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 25 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Hikma Injectables USA Inc has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Hikma Injectables USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Hikma Injectables USA Inc have FDA actions?
Hikma Injectables USA Inc has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0508-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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