D-0483-2026 Class II Ongoing

Recalled by International Medication Systems Ltd. — South El Monte, CA

Recall Details

Product Type
Drugs
Report Date
April 22, 2026
Initiation Date
April 1, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
81,520 units

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

Reason for Recall

Lack of Assurance of Sterility

Distribution Pattern

U.S. Nationwide

Code Information

Lot Number: EA038A5, Expiration Date: 08/2026.