FDA-Drug2026-04-22Class II
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
International Medication Systems Ltd.
Hazard
Lack of Assurance of Sterility
Sold states
U.S. Nationwide
Affected count
81,520 units
Manufactured in
1886 Santa Anita Ave, N/A, South El Monte, CA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0483-2026Original summary
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
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