Fresenius Kabi USA, LLC: Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 6332
Read the official notice at FDA (drug) →
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Fresenius Kabi USA, LLC
- Product
- Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton)
- Reason / hazard
- Failed Impurities/Degradations Specifications
- Classification
- Class III
- Status
- Ongoing
- Distribution / sold at
- US Nationwide.
- Recall initiated
- 2026-05-14
- Code info
- Batch # 6133313, 6133314, Exp Date: 06/2026; Batch # 6133315, Exp Date: 07/2026; Batch # 6133682, Exp Date: 09/2026; Batch # 6134812, 6134813, Exp Date: 04/2027.
- Product quantity
- 898,050 vials
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Lake Zurich
- State
- IL
- Country
- United States
- Event id
- 98997
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