Main Street Compounding Pharmacy Recalls Sodium Hyaluronate Vials
Main Street Family Pharmacy, LLC is recalling 24 units of Sodium Hyaluronate 6ml vials due to adverse reactions reported for 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 recall is classified as FDA Class II and involves reports of adverse reactions (skin abscesses), which aligns with the rubric criteria for Severe (FDA Class II with hospitalization reports or significant injury reports).
Plain-English summary
Main Street Family Pharmacy, LLC is recalling 24 units of Sodium Hyaluronate 6ml vials. The recall covers all codes distributed prior to and including May 23, 2013. 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 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, a different product manufactured by the same firm. The source text does not specify if the Sodium Hyaluronate vials themselves caused the abscesses, but the recall is associated with these reports.
Consumers who have this product should stop using it and contact the recalling firm for instructions on disposal or return. 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
- Sodium Hyaluronate 6ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200
- Manufacturer
- Main Street Family Pharmacy, LLC
- Category
- Drug — Compounded Injectable
- Affected units
- 24
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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