drugs Class II Updated 2012-08-22

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML;

Recalled Product

BACLOFEN/MORPHINE, P.F. 1,000MCG/25MG/ML INTRATHECAL 18 ML; BACLOFEN/MORPHINE, P.F. 1,500MCG/1.5MG/ML INTRATHECAL 40 ML; BACLOFEN/MORPHINE, P.F. 2,000MCG/25MG/ML INTRATHECAL 40 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:N0392050, N0391605, N0402936
View official government recall

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