Drug product
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)
D-1618-2012
Product summary
- Event
- Event 62443
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 units
- Official record key
drug-enforcement:D-1618-2012
Official wording
Reason: 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.
Code information: Rx #'s: 0395804 0395804 0404876 0405488 0404876 0403179 0403991 0407590 0407590 0394748 0394749 0403382 0405156 0401795 0401795 0400457 0400944 0392902 0406332 0398643 0405500 0397467
Distribution pattern: Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Derived failure modes
-
Microbial contamination
fungal growth
-
Sterility assurance
Lack of Assurance of Sterility