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.
SODIUM BICARBONATE 4% INJECTABLE 10 ML 5 ML; SODIUM BICARBONATE 8.4% INJECTABLE 150 ML 50 ML 5000 ML; SODIUM BICARBONATE, 50ML SDV** 8.4% (1MEQ/ML) INJECTABLE 100 MLS 250 ML; SODIUM BICARBONATE, MDV 8.4% INJECTABLE 100 ML 150 ML 200 ML; SODIUM CHLORIDE 0.9% (25X10ML) INJ. SDPF **** 0.9% INJECTABLE 25 VIAL 40 ML; SODIUM CHLORIDE (STERILE) 23.4% (20MEQ/5ML) SOLUTION 1000 ML 2500 ML; SODIUM CHLORIDE 0.9% BACTERIOSTATIC ** 0.9% INJECTABLE 30 MLS 750 ML; SODIUM CHLORIDE 0.9% IRRIGATION (24X250ML)** 0.9% SOLUTION 250 ML; SODIUM CHLORIDE 0.9%, 100ML I.V. BAG** 0.9% INJECTABLE 100 ML; SODIUM TETRADECYL SO4 3% INJECTABLE 20 ML; SODIUM TETRADECYL SULFATE 0.2 % INJECTABLE 30 ML (20 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 Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
Reason shortfill; reports of empty capsules.
Reason Presence of Particulate Matter: Hair was found in products
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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