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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Steroid
- 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
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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