Main Street Compounding Pharmacy Recalls Methylprednisolone Due to Skin Abscess Reports
Main Street Compounding Pharmacy is recalling methylprednisolone vials after seven reports of skin abscesses potentially linked to the product.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Main Street Family Pharmacy, LLC is recalling 697 units of Methylprednisolone 100mg/ml, 10ml vials (lot # 011213dan). The recall is being conducted by the U.S. Food and Drug Administration.
The firm initiated the recall after receiving seven reports of adverse reactions in the form of skin abscesses. These reactions were potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
The affected product was distributed nationwide to the following states and districts: 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. Consumers who possess this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Methylprednisolone 100mg/ml, 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Steroid
- Hazard
- Affected units
- 697
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)
- lot# 011213dan
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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