Main Street Compounding Pharmacy Recalls Estradiol Pellets Due to Adverse Reactions
Main Street Family Pharmacy is recalling 52 units of Estradiol Pellet 20mg due to seven reports of skin abscesses.
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 reported adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe severity involving significant injury reports or Class II classifications with reported harm.
Plain-English summary
Main Street Family Pharmacy, LLC is recalling 52 units of Estradiol Pellet 20mg. The product was 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 May 23, 2013.
The recall was initiated after 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 source text does not specify the exact mechanism linking the estradiol pellets to the methylprednisolone vials or the specific nature of the contamination.
Consumers who have received this product should contact their healthcare provider or the recalling firm at 888-658-6200 for instructions on how to proceed. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Estradiol Pellet 20mg, 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
- 52
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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