Agency classClass IIOur severity:Severe FDA (Drugs)·D-068-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Carnitine Due to Adverse Reactions

Main Street Family Pharmacy is recalling Carnitine 250mg/ml after receiving seven reports of skin abscesses potentially linked to the product.

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 specific adverse reactions (skin abscesses), which aligns with the rubric criteria for a Severe rating involving significant injury reports.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling Carnitine 250mg/ml, a compounded medication. 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 recalled product is distributed nationwide, specifically in 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 05/23/2013.

Consumers who have purchased this product should contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product: Carnitine 250mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Manufacturer: Main Street Family Pharmacy, LLC
Category: Drug — Compounded Medication
Hazard: skin-abscess
adverse-reaction
Affected units: 30

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 →

Same manufacturer · Main Street Family Pharmacy, LLC

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Same hazard · skin abscess