phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, Hikma Injectables USA Inc., 36 Stults Ro
Summary
The FDA issued a Class II for phenylephrine in 0.9% Sodium Chloride Inj, 1mg per 10 mL (100 mcg/mL), Rx only, by Hikma Injectables USA Inc. Reason: Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment..
Details
Source
Drug Recall
External ID
D-0174-2025
Action Date
2025-01-08
Status
Terminated
Category
drug
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
Lot/Code Info: Lot number: 243120003D, Use by Date: 03/11/2025
Reason for Recall
Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-12-19
Company
Dayton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 31 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 II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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-0174-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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