Agency classClass IIOur severity:Severe FDA (Drugs)·D-147-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls HCG 5000iu Kits

Main Street Family Pharmacy, LLC is recalling HCG 5000iu kits due to adverse reactions reported with a different compounded 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 the source text reports seven instances of adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity involving hospitalization or significant injury reports.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 222 units of HCG 5000iu kits. The recall covers products 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 includes all codes distributed prior to and including May 23, 2013.

The firm initiated this 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, a different product from the HCG kits listed in the recall notice.

Consumers who possess the recalled HCG 5000iu kits should stop using them and contact the recalling firm for further instructions.

The recalled product

Product: HCG 5000iu kit, 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: 222

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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Same hazard · skin abscess