Main Street Compounding Pharmacy Recalls Double Strength PGE1 40mcg 2ml
Main Street Compounding Pharmacy is recalling Double Strength PGE1 40mcg 2ml vials due to reports of skin abscesses linked to a related 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 recall is classified as FDA Class II and involves reported adverse reactions (skin abscesses), which aligns with the rubric criteria for a Severe rating involving significant injury reports.
Plain-English summary
Main Street Family Pharmacy, LLC is recalling Double Strength PGE1 40mcg 2ml 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 recalled 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. The recall includes all codes distributed prior to and including 05/23/2013.
Consumers who have this product should stop using it and contact the recalling firm, Main Street Family Pharmacy, LLC, at 888-658-6200 for further instructions.
The recalled product
- Product
- Double Strength PGE1 40mcg 2ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Drug
- 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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