The Recall Desk
SevereFDA (Drugs)·D-061-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Betamethasone 9mg/ml PF Vials

Main Street Compounding Pharmacy is recalling Betamethasone 9mg/ml PF vials due to reports of skin abscesses linked to a related 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 reported adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity involving significant injury reports.

Plain-English summary

Main Street Family Pharmacy, LLC is recalling 43 units of Betamethasone 9mg/ml PF (preservative-free) vials. The recall was initiated after the firm received seven reports of adverse reactions, specifically skin abscesses, potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.

The affected units were 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 May 23, 2013, are included in this recall.

Consumers and healthcare providers should stop using the recalled Betamethasone 9mg/ml PF vials and contact Main Street Family Pharmacy, LLC at 888-658-6200 for further instructions or a refund.

The recalled product

Product
Betamethasone 9mg/ml PF, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
Affected units
43

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 →