The Recall Desk
CriticalFDA (Drugs)·D-210-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Methylprednisolone Due to Skin Abscess Reports

Main Street Compounding Pharmacy is recalling methylprednisolone vials after seven reports of skin abscesses potentially linked to the product.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 697 units of Methylprednisolone 100mg/ml, 10ml vials (lot # 011213dan). The recall is being conducted by the U.S. Food and Drug Administration.

The firm initiated the recall after receiving seven reports of adverse reactions in the form of skin abscesses. These reactions were potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.

The affected product was distributed nationwide to the following states and districts: 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. Consumers who possess this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Methylprednisolone 100mg/ml, 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
697

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • lot# 011213dan

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 299 recalled by Main Street Family Pharmacy, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 299 products in this recall →