Agency classClass IIOur severity:Severe FDA (Drugs)·D-234-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Methylprednisolone Vials

Main Street Family Pharmacy is recalling 2 units of compounded methylprednisolone vials due to 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 recall is classified as FDA Class II and involves reported adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity (FDA Class II with hospitalization reports or significant injury).

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 2 units of Mic Combo w/methyl 30ml vials. The 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. The recall covers all codes distributed prior to and including May 23, 2013.

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 FDA has classified this recall as Class II.

Consumers who have this product should stop using it and contact Main Street Family Pharmacy at 888-658-6200 for instructions on how to return the product.

The recalled product

Product: Mic Combo w/methyl 30ml, 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
adverse-reaction
Affected units: 2

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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