The Recall Desk
SevereFDA (Drugs)·D-067-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Carnitine 250mg/ml Vials

Main Street Compounding Pharmacy is recalling Carnitine 250mg/ml vials due to 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 recall is classified as FDA Class II and involves reports of skin abscesses, which constitute significant injury reports under the severity rubric.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling Carnitine 250mg/ml vials. The recall involves 30 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 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 recalled Carnitine.

Consumers who possess the recalled Carnitine 250mg/ml vials should stop using them and contact Main Street Family Pharmacy, LLC at 888-658-6200 for further instructions.

The recalled product

Product
Carnitine 250mg/ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
30

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 →