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
Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: products were stored outside the drug label specifications.
What was recalled
Racepinephrine Inhalation Solution, USP 2.25%, Bronchodilator, For Oral Inhalation Only, Sulfite Free, Preservative Free, 30 x 0.5 mL Sterile Unit-of-Use Vials, each in a foil pouch, per carton, Nephron Pharmaceuticals Corporation, NDC 0487-5901-99.
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- NDC code
- 0487-5901-99
- Origin
- VA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1325-2022
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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