D-1540-2012 Class II Terminated
FDA drug recall D-1540-2012 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: 8 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
- 8 units
Product Description
HYDROMORPHONE P.F. 20MG/ML INTRATHECAL 40 ML; HYDROMORPHONE P.F. 25MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 30MG/ML INTRATHECAL 18 ML; HYDROMORPHONE P.F. 50MG/ML INTRATHECAL 40 ML (4 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:N0393645 N0399634 N0398233 N0388437 N0395176 N0396644 N0403778 N0396442
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1540-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026