Agency classClass IIOur severity:Severe FDA (Drugs)·D-200-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Medroxyprogesterone Due to Skin Abscess Reports

Main Street Family Pharmacy is recalling Medroxyprogesterone 150mg 10ml vials after receiving seven reports of skin abscesses 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 recall is classified as FDA Class II and involves reports of skin abscesses, which constitutes a significant injury report under the severity rubric.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling Medroxyprogesterone 150mg 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 units 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. The recall covers all codes distributed prior to and including 05/23/2013.

Consumers who have received this product should contact their healthcare provider or the recalling firm at 888-658-6200 for further instructions.

The recalled product

Product: Medroxyprogesterone 150mg 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Manufacturer: Main Street Family Pharmacy, LLC
Category: Drug — Compounded Injectable
Hazard: skin-abscess
infection
Affected units: 5

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