News & Press: Patient Safety

6/13 - Main Street Family Pharmacy Products: Samples of Injectable Methylprednisolone Acetate Test P

Friday, June 7, 2013  
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6/13 - Main Street Family Pharmacy Products: Samples of Injectable Methylprednisolone Acetate Test Positive for Microbial Contamination

 

 

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. FDA will share additional information as it becomes available.

For more information please visit: MainStreet


Source: U.S. Food and Drug Administration (FDA) (Accessed: 6/13/2013)
Update 6/7/2013 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 from Main Street Family Pharmacy. The microbial growth was seen in samples from two separate lots (batches). Additional samples and lots of PF MPA are still under evaluation, as well as other sterile products produced by Main Street. FDA, in partnership with CDC, is working to identify the exact species of fungus and bacteria observed in the vials. FDA has received reports of adverse events, including skin and soft tissue abscesses. To date, FDA is not aware of any cases of meningitis associated with Main Street’s preservative free methylprednisolone acetate for injection.

 

The FDA asks health care providers and consumers to report adverse events or quality problems experienced with this or any Main Street products to the FDA’s MedWatch Adverse Event Reporting program:

Read the Medwatch safety alert, including a link to the FDA Update HERE.

Source: U.S. Food and Drug Administration (FDA) (Accessed: 6/7/2013)


UPDATE 5/28/2013 Main Street Family Pharmacy, LLC has announced a voluntary nationwide recall of all lots of all sterile products compounded by the pharmacy. The compounded products that are subject to the recall are those with a use by date on or before November 20, 2013. The recall is being initiated due to seven (7) reported cases of adverse events in the form of skin abscesses, one of which appears to be fungal in nature. An investigation into the exact source of the adverse events is still ongoing.

 

These products were supplied to the offices of licensed medical professionals and patients. Sterile products included in this withdrawal were distributed nationwide.

Refer to the Firm Press Release for the list of productsbeing recalled.

Read the MedWatch Alert, including a link to the FDA News Release, HERE.

Source: U.S. Food and Drug Administration (FDA) (Accessed: 5/28/2013)


The U.S. Food and Drug Administration is working closely with the Centers for Disease Control and Prevention and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tenn.

Out of an abundance of caution, the FDA recommends that health care providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided.It is known that these products were distributed to facilities in 13 states, including: Alabama, Arkansas, California, Florida, Kentucky, Illinois, Louisiana, Mississippi, New Mexico, North Carolina, and South Carolina.

The reports of adverse events are all from patients who received preservative free methylprednisolone acetate (80 mg/mL) by injection. To date, the FDA has received seven reports. Clinical information about these patients is pending; at least one of these adverse events appears to involve fungus.

An investigation into the exact source of these adverse events is still ongoing, but these cases are associated with a potentially contaminated medication.As part of the ongoing investigation, the FDA will continue to work closely with the CDC and state authorities to thoroughly review the sterile practices at Main Street.

The FDA asks health care providers and consumers to report adverse events or quality problems experienced with the use of any Main Street products to the FDA’s MedWatch Adverse Event Reporting program:

• Complete and submit the report online at www.fda.gov/medwatch/report.htm

• Download and complete the form, then submit it via fax at 1-800-FDA-0178

Sources: U.S. Food and Drug Administration (FDA) and Illinois Department of Public Health (Accessed: 5/24/2013)


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