Main Street Compounding Pharmacy Recalls Betamethasone 7mg Due to Adverse Reactions
Main Street Family Pharmacy is recalling Betamethasone 7mg 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 7mg manufactured by Main Street Compounding Pharmacy in Newbern, Tennessee. The recall involves 932 units of the product, which 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 affected.
The firm initiated the recall after receiving 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 source text does not specify if the Betamethasone 7mg product itself contained methylprednisolone or if the adverse reactions were directly caused by the Betamethasone product, but the recall is associated with these reports.
Consumers who have purchased or received this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Betamethasone 7mg, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Steroid
- Affected units
- 932
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
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.
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