Agency classClass IIOur severity:Severe FDA (Drugs)·D-223-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Methylprednisolone Vials Due to Abscess Reports

Main Street Family Pharmacy, LLC is recalling preservative-free methylprednisolone 80mg/ml vials after seven reports of skin abscesses.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity involving Class II recalls with injury reports.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 2,187 units of Methylprednisolone 80mg PF 1ml vials. The recall was initiated after the firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to the compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.

The affected product was 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 distributed prior to and including 05/23/2013 are included in this recall.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: Methylprednisolone 80mg PF 1ml, 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: infection
skin-abscess
Affected units: 2,187

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 →

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