FDA DrugsClass II
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICA...
Published: April 22, 2026Recall ID: D-0483-2026Category: drugsCountry: US
Reason for Recall / Hazard
Lack of Assurance of Sterility
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | South El Monte |
| State | CA |
| Openfda › Nui › 1 | N0000000209 |
| Openfda › Nui › 2 | N0000000245 |
| Openfda › Nui › 3 | N0000175552 |
| Openfda › Nui › 4 | N0000175555 |
| Openfda › Nui › 5 | N0000175570 |
| Openfda › Nui › 6 | M0003647 |
| Openfda › Unii | YKH834O4BH |
| Openfda › Route | INTRAVENOUS |
| Openfda › Rxcui | 727373 |
| Openfda › Spl id | fde15adc-52e9-4f6e-8437-5a450934b280 |
| Openfda › Brand name | EPINEPHRINE |
| Openfda › Spl set id | f2b5f15b-8541-466a-a27a-ee57bc4aac67 |
| Openfda › Package ndc | 76329-3318-1 |
| Openfda › Product ndc | 76329-3318 |
| Openfda › Generic name | EPINEPHRINE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Catecholamines [CS] |
| Openfda › Substance name | EPINEPHRINE |
| Openfda › Pharm class epc › 1 | alpha-Adrenergic Agonist [EPC] |
| Openfda › Pharm class epc › 2 | beta-Adrenergic Agonist [EPC] |
| Openfda › Pharm class epc › 3 | Catecholamine [EPC] |
| Openfda › Pharm class moa › 1 | Adrenergic alpha-Agonists [MoA] |
| Openfda › Pharm class moa › 2 | Adrenergic beta-Agonists [MoA] |
| Openfda › Manufacturer name | International Medication Systems, Limited |
| Openfda › Application number | NDA211363 |
| Openfda › Is original packager | true |
| Event id | 98690 |
| Address 1 | 1886 Santa Anita Ave |
| Address 2 | N/A |
| Code info | Lot Number: EA038A5, Expiration Date: 08/2026. |
| Postal code | 91733-3414 |
| Report date | 20260422 |
| Product type | Drugs |
| Product quantity | 81,520 units |
| Reason for recall | Lack of Assurance of Sterility |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260401 |
| Initial firm notification | Letter |
| Center classification date | 20260414 |
Overview
- Recalling FirmInternational Medication Systems Ltd.
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide