The Recall Desk
SevereFDA (Drugs)·D-054-2014·Announced 2013-12-11

Main Street Compounding Pharmacy Recalls Betamethasone NA Phosphate Vials

Main Street Family Pharmacy is recalling two units of compounded Betamethasone NA Phosphate vials 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 (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 two units of Betamethasone NA Phosphate (PF) 6mg/ml 10ml vials. The recall is being conducted by the U.S. Food and Drug Administration.

The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. The source text does not specify if these reports are directly linked to the recalled Betamethasone product or if the methylprednisolone vials are part of the same recall event.

The recalled 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. All codes were distributed prior to and including 05/23/2013. Consumers should contact the recalling firm for further instructions.

The recalled product

Product
Betamethasone NA Phosphate (PF) 6mg/ml 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 →