Agency classClass IIOur severity:Severe FDA (Drugs)·D-123-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls HCG 240 iu Prefilled Syringes

Main Street Family Pharmacy, LLC is recalling 1,976 units of HCG 240 iu prefilled syringes 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 agency classification is FDA Class II, and the source text reports adverse reactions (skin abscesses) linked to the firm's compounded products, meeting the criteria for a Severe rating.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 1,976 units of HCG 240 iu prefilled syringes. The recall involves all codes distributed prior to and including May 23, 2013. The product was 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 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 than the HCG syringes being recalled. The source text does not specify if the HCG syringes themselves caused the abscesses or if the recall is precautionary due to shared compounding processes or facility issues.

Consumers who have purchased or received these HCG 240 iu prefilled syringes should stop using them and contact Main Street Family Pharmacy, LLC at 888-658-6200 for further instructions. The pharmacy is located at 126 East Main Street, Newbern, TN 38059.

The recalled product

Product: HCG 240 iu prefilled syringes, 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: 1,976

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