Status
Terminated
Drug Enforcement D-1559-2012
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.
Classification
Class II
Report Date
August 22, 2012
Termination Date
August 15, 2014
Product Information
- Product description
- LIDOCAINE HCL/BUPIVACAINE HCL PF 1%/0.375% OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE HCL/BUPIVACAINE/HYALURONIDASE PF 0.83%/0.312%/16.67U/ML OPHTHALMIC 30 ML 48 ML 60 ML 90 ML; LIDOCAINE/BUPIVACAINE/HYALURONIDASE PF 1.776%/0.335%/22.22UNITS/ML OPHTHALMIC 30 ML 60 ML (8 DIFFERENT PRODUCTS)
- Product quantity
- 20 units
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies
Location & Firm
- Recalling firm
- Franck's Lab Inc., d.b.a. Franck's Compounding Lab
- Address
-
1210 SW 33rd Avenue
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1559-2012
- Event ID
- 62443
- Recall initiation date
- May 21, 2012
- Center classification date
- August 10, 2012
- Code info
- Rx #'s: 0370177 0370177 0370177 0387585 0370177 0387584 0387584 0387584 0387584 0370176 0370176
- More code info
- —