Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
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 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
HYALURONIC ACID SODIUM SALT 10MG/ML INJECTABLE 100 ML, 20 ML; HYALURONIC ACID SODIUM SALT, P.F. 20MG/ML INJECTABLE 500 ML (3 DIFFERENT PRODUCTS)
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.
Reason cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and…
Reason Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Reason Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Reason Microbial Contamination of Non-Sterile Products: odor complaint of product due to microbial contamination.
Reason Lack of Assurance of Sterility: There are also CGMP Deviations.
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