The Recall Desk
SevereFDA (Drugs)·D-090-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Estradiol Pellets Due to Adverse Reactions

Main Street Family Pharmacy is recalling Estradiol Pellets 12.5mg 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 agency classification is FDA Class II, and the source text reports significant injury (skin abscesses), which meets the criteria for a Severe rating.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling Estradiol Pellets 12.5mg. The recall involves 334 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 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, a different product from the recalled estradiol pellets.

Consumers who have Estradiol Pellets 12.5mg from Main Street Compounding Pharmacy should contact the pharmacy at 888-658-6200 for further instructions.

The recalled product

Product
Estradiol Pellets 12.5mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
334

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 →