EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA
Summary
The FDA issued a Class II for EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICA by International Medication Systems Ltd.. Reason: Lack of Assurance of Sterility.
Details
Source
Drug Recall
External ID
D-0483-2026
Action Date
2026-04-22
Status
Ongoing
Category
drug
Product Description
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An Amphastar Pharmaceutical Company, NDC 76329-3318-1
Lot/Code Info: Lot Number: EA038A5, Expiration Date: 08/2026.
Quantity Affected: 81,520 units
Reason for Recall
Lack of Assurance of Sterility
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-01
Company
South El Monte, CA
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 94 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (International Medication Systems Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does International Medication Systems Ltd. have FDA actions?
This is the only FDA action we have on record for International Medication Systems Ltd. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0483-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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