The Recall Desk
SevereFDA (Drugs)·D-119-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls HCG 210 iu Prefilled Syringes

Main Street Family Pharmacy, LLC is recalling 56 units of HCG 210 iu prefilled syringes due to adverse reaction reports.

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 in the form of skin abscesses, which aligns with the rubric criteria for Severe (Class II with injury reports).

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 56 units of HCG 210 iu prefilled syringes. 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 recall includes all codes distributed prior to and including 05/23/2013.

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. The source text does not specify if the HCG syringes themselves were contaminated or if the adverse reactions were directly caused by the HCG product, only that the firm received reports linked to the methylprednisolone vials.

Consumers who have purchased or received these HCG 210 iu prefilled syringes should stop using them and contact the recalling firm, Main Street Family Pharmacy, LLC, at 888-658-6200 for further instructions.

The recalled product

Product
HCG 210 iu prefilled syringes, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
56

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 →