FDA recall D-071-2014

Product

Dexamethasone LA 16mg/ml 10ml, 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-071-2014