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  • Preliminary Microbial Identification of Main Street Family Pharmacy Products

    6/13/13

    As part of the ongoing FDA investigation of Main Street Family Pharmacy (Main Street) of Newbern, TN, FDA has identified bacterial and fungal growth in samples from two unopened vials of preservative-free (PF) methylprednisolone acetate (MPA) 80 mg/mL, 10mL vials. The microbial growth was seen in samples from two separate lots (batches). FDA and CDC laboratories, working together, provide the following preliminary microbial identification results:

    Medication

    Lot Number

    Preliminary Microbial Identification

    PF MPA 80 mg/mL - 10 mL per vial

    011413dan

    Bacillus pumilus, Bacillus cereus/thuringiensis/mycoides*, Roseomonas gilardii, Acinetobacter ursingii, Alternaria sp., Cladosporium sp.

    PF MPA 80 mg/mL - 10 mL per vial  

    010913dan

    Bacillus licheniformis, Penicillium sp.

    (*) unable to distinguish which species at this time

    Additional samples and lots of PF MPA are still under evaluation, as well as other sterile products produced by Main Street. We will share additional information as it becomes available.

    For more information please visit: MainStreet

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