International Medication Systems epinephrine injection recalled for sterility concerns
International Medication Systems Ltd. is recalling one lot of epinephrine injection due to concerns that the sterility of the product cannot be assured. The affected lot (EA038A5, expiring 08/2026) was distributed nationwide. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Stop using epinephrine injection lot EA038A5 immediately
- Contact your pharmacy or healthcare provider if you have this lot
- Do not use this medication; contact FDA or the manufacturer for instructions on safe disposal
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 81,520 units
- Illnesses reported
- None reported
- Manufactured in
- 1886 Santa Anita Ave, N/A, South El Monte, CA, United States
- Classification
- Class II
- Recall number
- D-0483-2026
In the FDA's words
- 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 Lack of Assurance of Sterility Lot Number: EA038A5, Expiration Date: 08/2026. Distribution: U.S. Nationwide Affected quantity: 81,520 units
- Hazard
- Lack of Assurance of Sterility