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
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors…
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Defective Delivery System; potential to have inaccurate dosage delivery
What was recalled
Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company
- Recalling firm
- Sanofi-Aventis U.S. LLC
- NDC code
- 0025-5833-02
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0872-2016
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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