The Recall Desk
SevereFDA (Drugs)·D-083-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Compounded Methylprednisolone Vials

Main Street Family Pharmacy, LLC is recalling compounded preservative-free methylprednisolone 80mg/ml 10 ml vials due to reports of skin abscesses.

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 reported adverse reactions (skin abscesses), meeting the criteria for a Severe rating.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 25 units of compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. 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 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. The recall covers all codes distributed prior to and including 05/23/2013.

Consumers and healthcare providers should stop using the recalled product and contact Main Street Family Pharmacy, LLC at 888-658-6200 for further instructions.

The recalled product

Product
EDTA 150mg/ml 100ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
25

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 →