The Recall Desk
SevereFDA (Drugs)·D-107-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls HCG 11000u w/B-12

Main Street Family Pharmacy is recalling HCG 11000u w/B-12 vials due to seven reports of skin abscesses linked to 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 seven instances of skin abscesses, which constitutes significant injury reports under the severity rubric.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 36 units of HCG 11000u w/B-12. The recall covers 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 the 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 11000u w/B-12 listed in the recall notice.

Consumers who have the recalled HCG 11000u w/B-12 should stop using it and contact Main Street Family Pharmacy, LLC at 888-658-6200 for instructions on how to return the product.

The recalled product

Product
HCG 11000u w/B-12, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
36

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 →