FDA Drug Class II — Moderate

DMSO/HEPARIN/METHYLPREDNISOLONE 50%/5000U/40MG/50ML SOLUTION 300 MLS (1 PRODUCT)

Hazard

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.

Products

DMSO/HEPARIN/METHYLPREDNISOLONE 50%/5000U/40MG/50ML SOLUTION 300 MLS (1 PRODUCT)
Brand
Franck's Lab Inc., d.b.a. Franck's Compounding Lab
UPC
Rx #: 0384672

Units Affected

2 units