The Recall Desk
HighFDA (Drugs)·D-094-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Estradiol Pellets Due to Adverse Reactions

Main Street Family Pharmacy is recalling Estradiol Pellets 31mg after receiving reports of skin abscesses linked to a different compounded product.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves reported adverse reactions (skin abscesses), which fits the 'High' severity criteria for risk-of-harm products where injury has been reported but is not classified as Class I or involving fatalities.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling Estradiol Pellets 31mg. The recall involves 7 units 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 05/23/2013.

The firm initiated this 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, a different product from the estradiol pellets listed in the recall metadata.

Consumers who have Estradiol Pellets 31mg from Main Street Compounding Pharmacy should stop using the product and contact the pharmacy at 888-658-6200 for further instructions.

The recalled product

Product
Estradiol Pellets 31mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
7

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 →