The Recall Desk
SevereFDA (Drugs)·D-214-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Methylprednisolone Due to Skin Abscess Reports

Main Street Compounding Pharmacy is recalling 166 units of compounded methylprednisolone after seven reports of skin abscesses potentially linked to the product.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves reported adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity (FDA Class II with hospitalization reports or significant injury reports).

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 166 units of Methylprednisolone 40mg 10ml compounded by Main Street Compounding Pharmacy in Newbern, Tennessee. The recall was initiated after 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.

The affected units were 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. All codes were distributed prior to and including 05/23/2013.

Consumers and healthcare providers should discontinue use of the recalled product and contact their healthcare provider or the recalling firm at 888-658-6200 for further instructions.

The recalled product

Product
Methylprednisolone 40mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
166

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)

  • all codes distributed prior to and including 05/23/2013

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 →