The Recall Desk
SevereFDA (Drugs)·D-259-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Pre-menopausal HCG Packs

Main Street Family Pharmacy, LLC is recalling Pre-menopausal HCG packs due to adverse reactions reported with a different compounded product.

What this means for you

Illness, injury, or structural failure has been reported. 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 reported adverse reactions (skin abscesses), meeting the criteria for a Severe rating.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 371 units of Pre-menopausal HCG packs. The recall covers all codes distributed prior to and including May 23, 2013. The products were 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 manufactured by the same firm.

Consumers who possess Pre-menopausal HCG packs should contact Main Street Compounding Pharmacy at 888-658-6200 for further instructions.

The recalled product

Product
Pre-menopausal HCG pack, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
371

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 →