The Recall Desk
SevereFDA (Drugs)·D-078-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Dexamethasone LA Due to Adverse Reactions

Main Street Compounding Pharmacy is recalling Dexamethasone LA 16mg 30ml vials after reports of skin abscesses linked to a related 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 recall is classified as FDA Class II and involves reported adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity involving significant injury reports.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling six units of Dexamethasone LA 16mg 30ml. The recall was initiated after 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 affected units were 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. All codes were distributed prior to and including 05/23/2013.

Consumers who have this product should contact Main Street Compounding Pharmacy at 888-658-6200 for instructions on how to return the product or obtain a refund.

The recalled product

Product
Dexamethasone LA 16mg 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
6

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 →