Agency classClass IOur severity:Critical FDA (Drugs)·D-220-2014·Announced 2013-12-11

FDA Recalls Compounded Methylprednisolone Vials Linked to Skin Abscesses

Main Street Family Pharmacy is recalling compounded methylprednisolone vials after seven reports of skin abscesses.

The agency’s classification

FDA (Drugs): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for compounded preservative-free methylprednisolone 80mg/ml 10ml vials manufactured by Main Street Family Pharmacy, LLC. The recall involves 1,312 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. Affected lot numbers are 012813dan, 011413dan, and 010913dan.

The firm initiated the recall after receiving seven reports of adverse reactions in the form of skin abscesses potentially linked to the product. The FDA classifies this as a Class I recall, which is the most serious type of recall, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.

Consumers and healthcare providers should stop using the affected vials immediately and contact their healthcare provider for further instructions. The recalling firm is Main Street Family Pharmacy, LLC, located at 126 East Main Street, Newbern, TN 38059.

The recalled product

Product: Methylprednisolone 80mg/ml (PF) 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Manufacturer: Main Street Family Pharmacy, LLC
Category: Drug — Compounded Steroid
Hazard: skin-abscess
infection
Affected units: 1,312

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 (3)

Lot# 012813dan
011413dan
010913dan

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 →

Same manufacturer · Main Street Family Pharmacy, LLC

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Same hazard · skin abscess