Home / Recalls / Franck's Lab Inc., D.B.A. Franck's Compounding Lab / D-1618-2012

D-1618-2012 Class II Terminated

Recalled by Franck's Lab Inc., D.B.A. Franck's Compounding Lab — Ocala, FL

FDA drug recall D-1618-2012 was initiated by Franck's Lab Inc., D.B.A. Franck's Compounding Lab on May 21, 2012 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Aug 15, 2014). Affected quantity: 24 units.

Recall Details

Product Type: Drugs
Report Date: Aug 22, 2012
Initiation Date: May 21, 2012
Termination Date: Aug 15, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 24 units

Product Description

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)

Reason for Recall

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.

Distribution Pattern

Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1618-2012
openFDA file date: Oct 26, 2026
Loaded by RegDataLab: Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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