The Recall Desk
SevereFDA (Drugs)·D-031-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Alprostadil Due to Adverse Reaction Reports

Main Street Family Pharmacy is recalling Alprostadil 100mcg/ml 10ml vials 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 specific adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity involving reported injuries or significant health issues.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling Alprostadil 100mcg/ml 10ml vials. The recall involves 8 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 May 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 Alprostadil being recalled.

Consumers who have purchased or received Alprostadil 100mcg/ml 10ml vials from Main Street Compounding Pharmacy should stop using the product and contact the pharmacy at 888-658-6200 for instructions on return or disposal.

The recalled product

Product
Alprostadil 100mcg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
8

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 →