Main Street Compounding Pharmacy Recalls Methylprednisolone Acetate Vials
Main Street Family Pharmacy is recalling 22 units of compounded methylprednisolone acetate vials due to reports of skin abscesses.
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 or Class II classifications with adverse events.
Plain-English summary
Main Street Family Pharmacy, LLC is recalling 22 units of Methylprednisolone Acetate 80mg 1ml vials. The recall is being conducted because the firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to the compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
The affected products were 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. All codes distributed prior to and including 05/23/2013 are included in this recall.
Consumers and healthcare providers who have these products should stop using them and contact Main Street Family Pharmacy, LLC at 888-658-6200 for instructions on return or disposal.
The recalled product
- Product
- Methylprednisolone Acetate 80mg 1ml, 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
- 22
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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