D-1529-2012 Class II Terminated
FDA drug recall D-1529-2012 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: 47 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
- 47 units
Product Description
GLUTATHIONE INHALATION 30MG/ML SOLUTION 120 ML, 60 ML; GLUTATHIONE P.F. 200MG/ML INJECTABLE 10 ML, 100 ML, 14 ML, 150 ML, 175 ML, 20 ML, 30 ML, 300 ML, 40 ML, 40 MLS, 50 ML, 58 MLS, 70 ML; GLUTATHIONE P.F. 50MG/ML (500MG/10ML) INJECTABLE 100 ML, 150 ML, 20 ML, 40 ML, 60 ML; GLUTATHIONE-FFC 100MG/ML INJECTABLE 20 ML (21 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: 0389833 0394741 0392912 0388244 0397159 0399176 0388244 0405177 0409379 0392912 0397159 0377235 0408837 0402247 0388244 0397159 0403342 0404418 0388244 0393276 0393276 0351537 0393276 0351537 0393276 0390499
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1529-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026