The Recall Desk
SevereFDA (Drugs)·D-262-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Sermorelin 15mg Due to Adverse Reactions

Main Street Compounding Pharmacy is recalling Sermorelin 15mg after receiving reports of skin abscesses linked to a different compounded 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 adverse reactions (skin abscesses), which aligns with the 'Severe' criteria for significant injury reports.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 12 units of Sermorelin 15mg. The recall was initiated after the firm received 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 Sermorelin 15mg 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 distributed prior to and including 05/23/2013 are included in this recall.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Sermorelin 15mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
12

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 →