NADH/Carnitine/Taurine/B12
Lack of Assurance of Sterility
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
NADH 10MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th St., Erie, PA.
Drug: Nadh
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
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