The Recall Desk
SevereFDA (Drugs)·D-149-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls HCG 60 iu Prefilled Syringes

Main Street Family Pharmacy, LLC is recalling HCG 60 iu prefilled syringes due to adverse reactions reported for 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 agency classification is FDA Class II, and the source text reports adverse reactions (skin abscesses) linked to a compounded product from the same firm, meeting the criteria for a Severe rating.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling HCG 60 iu prefilled syringes. The recall involves 3 units of the product 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 covers all codes distributed prior to and including 05/23/2013.

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 syringes listed in the recall notice.

Consumers who have the recalled HCG 60 iu prefilled syringes should stop using them and contact Main Street Family Pharmacy, LLC at 888-658-6200 for instructions on how to return the product.

The recalled product

Product
HCG 60 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
3

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 →