The Recall Desk
SevereFDA (Drugs)·D-102-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Gomenol Due to Skin Abscess Reports

Main Street Family Pharmacy, LLC is recalling Gomenol 10ml vials 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 reports of significant injury (skin abscesses), which meets the criteria for a Severe rating.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 15 units of Gomenol 10ml, a compounded preservative-free methylprednisolone 80mg/ml solution. The recall was initiated after the firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to the product.

The affected units were distributed nationwide to specific states including 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. The recall covers all codes distributed prior to and including May 23, 2013.

Consumers who have this product should stop using it and contact Main Street Family Pharmacy, LLC at 888-658-6200 for instructions on how to return the product.

The recalled product

Product
Gomenol 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
15

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 →