D-0483-2026 Class II Ongoing
FDA drug recall D-0483-2026 was initiated by International Medication Systems Ltd. on April 1, 2026 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 81,520 units.
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.