The Recall Desk
SevereFDA (Drugs)·D-058-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Betamethasone Due to Skin Abscess Reports

Main Street Family Pharmacy is recalling Betamethasone 6mg PF 10ml vials after receiving seven reports of skin abscesses potentially linked to the 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, meeting the criteria for a Severe rating.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling Betamethasone 6mg PF 10ml vials. The recall was initiated after the firm received seven reports of adverse reactions in the form of skin abscesses. These reactions are potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.

The affected product is Betamethasone 6mg PF 10ml, manufactured by Main Street Compounding Pharmacy located at 126 East Main Street, Newbern, TN 38059. The recall covers 2 units of the product. Distribution was nationwide, specifically 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. Consumers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on disposal or replacement.

The recalled product

Product
Betamethasone 6mg PF 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
2

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 →