The Recall Desk
SevereFDA (Drugs)·D-109-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls HCG 140 iu Prefilled Syringes

Main Street Family Pharmacy, LLC is recalling HCG 140 iu prefilled syringes due to reports of adverse reactions linked to compounded preservative-free methylprednisolone.

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 reports 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 HCG 140 iu prefilled syringes. The recall involves 3 units 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. All codes distributed prior to and including 05/23/2013 are affected.

The recall was initiated after the firm received 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.

Consumers should check their inventory for the affected HCG 140 iu prefilled syringes. If found, they should stop using the product and contact Main Street Family Pharmacy, LLC at 888-658-6200 for instructions on disposal or return.

The recalled product

Product
HCG 140 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 →