The Recall Desk
SevereFDA (Drugs)·D-279-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls TCA 30% Vials

Main Street Compounding Pharmacy is recalling TCA 30% vials due to adverse reactions reported for 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 Class II, and the source text reports adverse reactions in the form of skin abscesses, which aligns with the rubric criteria for Severe severity involving injury reports.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling TCA 30% - 0.8PH 15ml vials. The recall is associated with the pharmacy's compounded products.

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 recall covers units distributed nationwide, including specific states such as 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 includes all codes distributed prior to and including 05/23/2013.

The recalled product

Product
TCA 30% - 0.8PH 15ml vial, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
1

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 →