FDA recall D-171-2014

Main Street Family Pharmacy, LLC · Class II · drug

Product

Lipo Blast w/o adenosine,Methionine 25mg, Inositol 50 mg, Choline 100mg, Methyl B-12 .25mg, B6 25mg, B5 12.5 mg, Lidocaine 10mg, B7 5mg, B1 12.5mg, B2 2.5mg, B3 12.5mg, Benzyl Alcohol .02ml 50ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

Reason for recall

The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.

Distribution

nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV

Key facts

Status: Terminated
Initiation date: 2013-05-28
Report date: 2013-12-11
Termination date: 2014-04-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: Newbern, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-171-2014