Main Street Compounding Pharmacy Recalls EDTA 3% 30ml Vials
Main Street Family Pharmacy is recalling EDTA 3% 30ml vials due to reports of adverse reactions linked to a different compounded 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 agency classification is FDA Class II, and the source text reports seven instances of adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity involving hospitalization or significant injury reports.
Plain-English summary
Main Street Family Pharmacy, LLC is recalling EDTA 3% 30ml vials. The recall is being conducted because the firm received 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 units are EDTA 3% 30ml vials 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. The recall covers all codes distributed prior to and including 05/23/2013.
Consumers should stop using the recalled EDTA 3% 30ml vials and contact Main Street Family Pharmacy at 888-658-6200 for further instructions.
The recalled product
- Product
- EDTA 3% 30ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Medication
- Affected units
- 1
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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