Agency classClass IIOur severity:Severe FDA (Drugs)·D-211-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Methylprednisolone Vials Due to Skin Abscesses

Main Street Family Pharmacy is recalling 198 units of compounded methylprednisolone 100mg w/lidocaine 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 recall is classified as FDA Class II and involves reported adverse reactions (skin abscesses), which aligns with the 'Severe' criteria for Class II recalls with injury reports.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 198 units of Methylprednisolone 100mg w/lidocaine, 10ml vials. The recall was initiated after the firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.

The affected products were distributed nationwide to the following states and districts: 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 who have this product should stop using it and contact their healthcare provider or the recalling firm at 888-658-6200 for further instructions.

The recalled product

Product: Methylprednisolone 100mg w/lidocaine, 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: infection
adverse-reaction
Affected units: 198

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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