D-1480-2012 Class II Terminated
FDA drug recall D-1480-2012 was initiated by Franck's Lab Inc., D.B.A. Franck's Compounding Lab on May 25, 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 because FDA environmental sampling revealed the presence… The recall status is terminated (terminated Aug 13, 2014). Affected quantity: 21 units.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 22, 2012
- Initiation Date
- May 25, 2012
- Termination Date
- Aug 13, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units
Product Description
CALCIUM CHLORIDE DIHYDRATE, P.F. 100MG/ML (10%) INJECTABLE 200 ML, 240 ML, 500 ML; CALCIUM EDTA 150MG/ML INJECTABLE 1000 ML, 800 ML, 900 ML; CALCIUM EDTA 300MG/ML INJECTABLE 400 ML, 500 ML; CALCIUM GLUCONATE OPHTHALMIC IN ARTIFICIAL TEARS 1% OPHTHALMIC 500 ML (9 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 because 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, and West Indies
Code Information
Rx #'s: 0392865 0396841 0392865 0389079 0401264 0401264 0389079 0351538 0379811 0398960 0396622 0367514
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1480-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026