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. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.
ONDANSETRON HCL, MDV 2MG/ML (40MG/20ML) INJECTABLE 200 ML 40 ML 400 ML 48 ML 600 ML 800 ML; ONDANSETRON HCL, P.F. 2MG/ML (4MG/2ML) INJECTABLE 20 ML 200 ML 24 ML 40 ML 48 ML (11 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 Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Reason Failed pH Specifications
Reason Lack of sterility assurance
Reason Lack of assurance of sterility.
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