FDA-Drug2013-12-11Class II

HCG 5,000U, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

Main Street Family Pharmacy, LLC
Hazard

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.

Sold states
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
Affected count
2188 units
Manufactured in
126 East Main Street, N/A, Newbern, TN, United States
Products
HCG 5,000U, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-145-2014

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