drugs Class II Updated 2012-08-22

Franck's Lab Inc., d.b.a. Franck's Compounding Lab recalls HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/

Recalled Product

HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1000MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% NACL) 50MG/1500MCG/7.5MG/ML INTRATHECAL 18 ML; HYDROMORPHONE/BACLOFEN/BUPIVACAINE (0.9% SODIUM CHLORIDE) 50MG/500MCG/7.5MG/ML I 18 ML (3 DIFFEENT 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:N0391871 N0395248 N0400014 N0404731 N0404936 N0408940 N0387888
View official government recall

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