Drug product
BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 1000MCG/7.5MG/1000MCG/50MG/ML INTR 40 ML; BACLOFEN/BUPIVACAINE/CLONIDINE/MORPHINE, P.F. 50MCG/2MG/200MCG/50MG/ML INTRATHEC 18 ML; BACLOFEN/CLONIDINE/BUPIVACAINE/MORPHINE, P.F. 500MCG/1/7.5/50MG/ML INTRATHECAL 40 ML (3 DIFFERENT PRODUCTS)
D-1460-2012
Product summary
- Event
- Event 62416
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 units
- Official record key
drug-enforcement:D-1460-2012
Official wording
Reason: 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.
Code information: Rx #'s:N0406290, N0387600, N0390988, N0393344, N0396645, N0400013, N0403729, N0406665, N0410203, N0393490
Distribution pattern: Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, and West Indies
Derived failure modes
-
Microbial contamination
fungal growth
-
Sterility assurance
Lack of Assurance of Sterility