drugs Class II Updated 2012-08-22

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10

Recalled Product

HYDROMORPHONE/CLONIDINE P. F. 120MG/1.3MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 120MG/1.8MCG/ML INTRATHECAL 10 ML; HYDROMORPHONE/CLONIDINE P. F. 80MG/1.2MCG/ML INTRATHECAL 10 ML (3 DIFFERENT PRODUCTS)

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Rx #'s:N0395798 N0397394 N0392201 N0400799 N0403781 N0407180 N0390189
View official government recall

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