Agency classClass IIOur severity:Severe FDA (Drugs)·D-104-2014·Announced 2013-12-11

FDA Recalls Compounded HCG 10000u Due to Adverse Skin Reactions

Main Street Family Pharmacy is recalling HCG 10000u vials after reports of skin abscesses linked to compounded methylprednisolone.

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 are significant injury reports consistent with the 'Severe' rubric criteria.

Plain-English summary

The U.S. Food and Drug Administration has issued a Class II recall for HCG 10000u compounded by Main Street Family Pharmacy, LLC. The recall involves 180 units of the product distributed nationwide to specific states and the District of Columbia.

The firm initiated the recall after receiving 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 source text does not specify if the HCG product itself contained the methylprednisolone or if the reports were associated with a separate product line from the same facility.

Consumers who have purchased HCG 10000u from Main Street Compounding Pharmacy should contact the firm at 888-658-6200 for instructions on how to return the product. The recall covers all codes distributed prior to and including May 23, 2013.

The recalled product

Product: HCG 10000u, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Manufacturer: Main Street Family Pharmacy, LLC
Category: Drug — Compounded Prescription
Hazard: skin-abscess
adverse-reaction
Affected units: 180

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