Class III · Low risk Ongoing
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02…
Reason Failed Impurities/Degradations Specifications
Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
What was recalled
Epinephrine 1:1,000 (1mg/mL) Sterile Solution for injection, Preservative Free/Sulfite Free, 1-mL Single-Use Syringe, Sterile Solution For Office Use Only, JCB Laboratories, Wichita, KS.
- Recalling firm
- JCB Labs LLC
- Origin
- KS, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1047-2013
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Epinephrine recalls
See all
Class II · Moderate risk Ongoing
EPINEPHRINE Injection, USP, 1 mg/10mL (0.1 mg/mL), Rx only, INTERNATIONAL MEDICATION SYSTEMS, LIMITED, So. EL Monte, CA 91733, An…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita…
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk Ongoing
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita…
Reason Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Class II · Moderate risk Ongoing
MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source…
Reason Stability Data Does Not Support Expiry Date.
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